Title:	A Phase II Study Evaluating the Role of Sentinel Lymph Node Surgery and Axillary Lymph Node Dissection Following Preoperative Chemotherapy in Women with Node Positive Breast Cancer (T1-4, N1-2, M0) at Initial Diagnosis - IRB #09-071B
Treatments:	Surgery
Disease Site:	Breast
Disease SubSite:	Node positive
Drug Provided:	-- none --
Comments:
Eligibility:	This is a multicenter study. Patients receive neoadjuvant chemotherapy at the discretion of the treating physician. Patients undergo examination for breast and axilla lymph adenopathy and then undergo ultrasound of the axillary nodes at baseline and after completion of neoadjuvant chemotherapy. Within 6 weeks of completing neoadjuvant chemotherapy, patients undergo a mastectomy or lumpectomy including sentinel lymph node and axillary lymph node dissection. After completion of study treatment, patients are followed every 6 months for 2 years, yearly for 2 years, then every other year for 6 years.

Title:	A Trial of Single Autologous Transplant with or without Consolidation Therapy versus Tandem Autologous Transplant with Lenalidomide Maintenance for Patients with Multiple Myeloma - IRB #10-057A
Treatments:	Bortezomib (Velcade™, PS-341), Dexamethasone, Lenalidomide, Stem Cell Transplantation
Disease Site:	Multiple myeloma
Disease SubSite:
Drug Provided:	Bortezomib (Velcade™, PS-341), Lenalidomide
Comments:	Providence Portland Medical Center is the site that is able to register patients. For potential patient referrals contact Sarah Linehan, transplant coordinator at x58646 or email: sarah.linehan@providence.org. You may also contact Roxanne Payne, FNP at x56737 or email: Roxanne.payne@providence.org.
Eligibility:	Patients must meet the criteria for symptomatic multiple myeloma, and patients who are 70 years of age, or younger, at time of enrollment. Patients who have received at least two cycles of any regimen as initial systemic therapy and are within 2-12 months of the first dose of initial therapy (this time frame excludes the time for mobilization therapy). Patients must be able to receive high-dose melphalan within 8 weeks after the initiation of mobilization therapy whether delivered at the transplant center or at a referring center. Cardiac function: left ventricular ejection fraction at rest greater than 40 percent. Hepatic: bilirubin less than 2 times the upper limit of normal and ALT and AST less than 2.5 times the upper limit of normal. Renal: Creatinine clearance of grater than or equal to 40 mL/min, estimated or calculated. Pulmonary: DLCO, FEV1, FVC grater than 50 percent of predicted value (corrected for hemoglobin). Patients with an adequate autologous graft defined as a cryopreserved PBSC graft containing greater than or equal to 4 x 10^6 CD34+ cells/kg patient weight. The graft may not be CD34+ selected or otherwise manipulated to remove tumor or other cells. The graft can be collected at the transplanting institution or by a referring center. The autograft must be stored so that there are two products each containing at least 2 x 10^6 CD34+ cells/kg patient weight.

Title:	A Phase III Randomized Trial of Lobectomy versus Sublobar Resection for Small (<=2 cm) Peripheral Non-Small Cell Lung Cancer - IRB# 08-125B
Treatments:	Lobectomy, Sublobar Resection
Disease Site:	Lung
Disease SubSite:	Non Small Cell Lung
Drug Provided:	-- none --
Comments:	INVESTIGATORS MUST CREDENTIALED TO ENROLL ON THIS STUDY.
Eligibility:	Suspected or proven Non-Small Cell Lung Cancer (NSCLC), meeting both preoperative and intraoperative criteria: Preoperative criteria, Peripheral lung nodule =<2 cm by CT scan. Center of the tumor must be located in the outer third of the lung in either the transverse, coronal, or sagittal plan. Tumor location must be suitable for either lobar or sublobar resection (wedge resection or segmentectomy). No pure ground opacities or pathologically confirmed N1 or N2 disease. Intraoperative criteria: Histologically confirmed NSCLC. Confirmation of N0 status by frozen section examination of nodal levels 4, 7, and 10 on the right side and 5, 6, 7, and 10 on the left side* Levels 4 and 7 nodes may be sampled by mediastinoscopy or at the time of thoracotomy or video-assisted thoracoscopic surgery (VATS) exploration* [Note: *Nodes previously sampled by mediastinoscopy either immediately prior to or within 6 weeks of the definitive surgical procedure (thoracotomy or VATS) do not need to be resampled] No evidence of locally advanced or metastatic disease. Prior/Concurrent Therapy: No prior chemotherapy or radiotherapy for this malignancy. Patient Characteristics: ECOG performance status 0-2. No other malignancy within the past 5 years except for nonmelanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix.

Title:	Randomized, Phase III, Placebo-Controlled Trial of Sunitinib as Maintenance Therapy in Non-Progressing Patients Following an Initial Four Cycles of Platinum-Based Combination Chemotherapy in Advanced, Stage IIIB/IV Non-Small Cell Lung Cancer - IRB# 08-127B
Treatments:	Sunitinib
Disease Site:	Lung
Disease SubSite:	Non Small Cell Lung
Drug Provided:	Sunitinib
Comments:
Eligibility:	Histologically or cytologically confirmed primary Non-Small Cell Lung cancer (NSCLC). Stage IIIB or IV disease: Not a candidate for combined modality therapy (chemoradiotherapy). Brain mets are allowed as long as they are treated. No evidence of spinal cord compression, or carcinomatous meningitis. No cavitary lesions. Must have received one prior first-line chemotherapy regimen that included 4 courses of platinum-based doublet chemotherapy with or without bevacizumab (bevacizumab may not have been given beyond the fourth course of chemotherapy). Must have achieved a complete response, partial response, or stable disease to first-line chemotherapy and have no evidence of disease progression. Completed the fourth course of first-line chemotherapy 3-5 weeks prior to study entry. Measurable or nonmeasurable disease. Measurable disease is defined as => 1 unidimensionally measurable lesion => 2 cm by conventional techniques or => 1 cm by spiral CT scan. Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter < 20 mm by conventional techniques or < 10 mm by spiral CT scan), truly nonmeasurable lesions, and any of the following: Bone lesions, Leptomeningeal disease, Ascites, Pleural/pericardial effusion, Lymphangitis cutis/pulmonis, Abdominal masses that are not confirmed and followed by imaging techniques, Cystic lesions.

Title:	Cyclophosphamide and Doxorubicin (CA) (4 vs. 6 Cycles) Versus Paclitaxel (4 vs. 6 Cycles) as Adjuvant Therapy for Breast Cancer in Women with 0-3 Positive Axillary Lymph Nodes: A 2X2 Factorial Phase III Randomized Study - IRB# 03-69A
Treatments:	Cyclophosphamide, Dexamethasone, Doxorubicin, Paclitaxel
Disease Site:	Breast
Disease SubSite:	0-3 Positive Nodes
Drug Provided:	-- none --
Comments:
Eligibility:	Histologically confirmed invasive carcinoma of the breast with 0-3 positive axillary lymph nodes. Meets 1 of the following criteria for node-negative disease: Negative sentinel lymph node biopsy, At least 6 negative axillary lymph nodes removed and determined to be negative by axillary dissection. Meets 1 of the following criteria for node-positive disease (1-3 positive axillary lymph nodes): At least 1 positive lymph node by sentinel lymph node biopsy AND at least 6 axillary lymph nodes removed by axillary dissection; of all the nodes removed from both the sentinel lymph node biopsy and the axillary dissection, 1-3 must be positive, At least 6 lymph nodes removed by axillary dissection; 1-3 nodes from the axillary dissection must be positive. "High-risk" disease that warrants chemotherapy (ultimately determined by the treating physician). Modified radical mastectomy or lumpectomy within the past 84 days required. Negative tumor margins for invasive cancer and ductal carcinoma in situ. Lobular carcinoma in situ at the margin allowed. Multicentric disease allowed provided margins and axillary nodes are negative after resection. Bilateral synchronous disease allowed. No locally advanced, inflammatory, or metastatic breast cancer . No dermal lymphatics involvement, even if there are no clinical signs of inflammatory cancer. HER2/neu positive, negative, or unknown. Hormone receptor status: Any estrogen and/or progesterone receptor status. Prior/Concurrent Therapy: Biologic therapy: No prior trastuzumab (Herceptin®) for this malignancy. Chemotherapy: See Disease Characteristics, No prior chemotherapy for this malignancy, No other concurrent chemotherapy. Endocrine therapy: No prior hormonal therapy for this malignancy except tamoxifen given for up to 4 weeks, Prior tamoxifen or other selective estrogen receptor modulators (SERMs) for prevention or other indications (e.g., osteoporosis) allowed, No concurrent exogenous hormonal therapy.

Title:	A Randomized Phase III Trial of Weekly Paclitaxel Compared to Weekly Nanoparticle Albumin Bound (Nab)-Paclitaxel or Ixabepilone Combined with Bevacizumab as First or Second-Line Therapy for Locally Recurrent or Metastatic Breast Cancer - IRB# 09-006A
Treatments:	Bevacizumab, Ixabepilone, Nab-paclitaxel, Paclitaxel
Disease Site:	Breast
Disease SubSite:	Metastatic breast
Drug Provided:	Bevacizumab, Ixabepilone, Nab-paclitaxel
Comments:
Eligibility:	Histologically confirmed invasive breast cancer. Stage IIIB or IV (locally recurrent or metastatic) disease not amenable to local therapy. Measurable disease (target lesions), defined as =>1 lesion that can be accurately measured in => 1 dimension (longest diameter to be recorded) as => 2.0 cm with conventional techniques or as => 1 cm with spiral CT scan. No non-measurable lesions, including any of the following: Ascites, Pleural/pericardial effusion, Inflammatory breast disease, Lymphangitis cutis/pulmonitis, Bone lesions, Leptomeningeal disease, Cystic lesions, Abdominal masses not confirmed and followed by imaging techniques, No prior chemotherapy regimen for metastatic or locally advanced breast cancer, HER2/neu status must be known, HER2- positive disease allowed, provided patient received prior trastuzumab (Herceptin®) or lapatinib (documentation of progression on HER2-directed therapy is not required), Hormone receptor status must be known, Estrogen receptor (ER)- and progesterone receptor (PgR)-positive if => 1% cells are positive. No progressing or untreated CNS metastases or leptomeningeal disease. History of resected brain metastases with stable MRI scans for 3 months including within the past 4 weeks allowed. History of gamma-knife radiosurgery or whole-brain radiation with stable MRI scans for 3 months, including within the past 4 weeks allowed.

Title:	A Randomized, Double-Blind, Placebo-Controlled Phase III Trial of Endocrine Therapy Alone or Endocrine Therapy Plus Bevacizumab (NSC 704865; IND 7921) for Women with Hormone Receptor-Positive Advanced Breast Cancer - IRB# 08-126A
Treatments:	Bevacizumab, Goserelin, Letrozole, Leuprolide, Tamoxifen
Disease Site:	Breast
Disease SubSite:	Advanced Breast Cancer HR+
Drug Provided:	Bevacizumab, Letrozole
Comments:
Eligibility:	Histologic confirmation of invasive cancer of the female breast in either the primary or metastatic setting. Stage IIIB disease not amenable to local therapy or stage IV disease. Must have measurable or nonmeasurable disease by RECIST criteria, with radiologic scans (CT scan of the chest/abdomen). Measurable disease is defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as =>2.0 cm with conventional techniques or as => 1.0 cm with spiral CT scan. Nonmeasurable disease is defined as all other lesions, including small lesions (longest diameter < 2.0 cm with conventional techniques or < 1.0 cm with spiral CT scan) and truly nonmeasurable lesions, including any of the following: Bone lesions, Leptomeningeal disease, Ascites, Pleural/pericardial effusion, Inflammatory breast disease, Abdominal masses that are not confirmed and followed by imaging techniques, Cystic lesions. Baseline bone scans required for all patients for determination of metastatic bone disease. CT scan with bone windows required only for patients with bone metastases as the only site of disease. No known CNS metastases or leptomeningeal disease (screening with brain imaging is not required for asymptomatic patients). Hormone receptor status: tumors (from either primary or metastatic sites) must express estrogen receptor (ER) and/or progesterone receptor (PgR) in => 1% of cells.

Title:	A Randomized, Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer -IRB# 09-053B
Treatments:	Zoledronic Acid
Disease Site:	Cancer control
Disease SubSite:	Bone Metastases
Drug Provided:	-- none --
Comments:
Eligibility:	Histologically confirmed breast adenocarcinoma, prostate adenocarcinoma, or multiple Myeloma. Has >= 1 site of bone metastasis or bone involvement by radiologic imaging (e.g., radiography, computed tomography, magnetic resonance imaging, or bone scan). No known brain metastases. Patients who develop brain metastases during the study are allowed to continue study treatment as assigned. Prior non-investigational chemotherapy, biologic therapy, and endocrine therapy in the adjuvant or metastatic setting allowed. No prior treatment with IV bisphosphonates. No prior treatment with radiopharmaceuticals. At least 4 weeks since prior radiotherapy. At least 1 site of bone metastasis must not have been irradiated. No concurrent investigational agent(s). No concurrent treatment with other agents expected to alter osteoclast activity (e.g., calcitonin, mithramycin, gallium nitrate, or any other bisphosphonate). Concurrent non-investigational antineoplastic therapies, including antiandrogens, other hormonal agents, cytotoxic chemotherapy agents, and biologic response modifiers allowed. Concurrent standard radiotherapy to extraskeletal and/or skeletal tumor sites allowed.

Title:	A Randomized Phase III Study of Gemcitabine, Cisplatin, Bevacizumab or Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma - IRB# 09-090B
Treatments:	Bevacizumab, Cisplatin, Gemcitabine
Disease Site:	Genitourinary
Disease SubSite:	Bladder
Drug Provided:	Bevacizumab
Comments:
Eligibility:	Histologically confirmed transitional cell carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate, or urethra). Unresectable or progressive metastatic or locally advanced disease (T4b, N2, N3 or M1). Not a candidate for potentially curative surgery or radiotherapy. No history of peritoneal carcinomatosis. No known brain metastases. Prior/Concurrent Therapy: At least 4 weeks since prior radiotherapy (including palliative radiotherapy) or major surgery and recovered. At least 4 weeks since prior intravesical therapy. No prior combination systemic chemotherapy for metastatic disease. Single-agent radiosensitizing chemotherapy is not considered prior systemic therapy. Prior neoadjuvant or adjuvant systemic chemotherapy allowed provided it was completed => 1 year prior to the diagnosis of metastatic disease. No prior bevacizumab or other angiogenesis inhibitors. No concurrent radiotherapy (including palliative radiotherapy). Concurrent full-dose anticoagulants allowed provided patient is on a stable dose of warfarin and has an in-range INR (between 2 and 3) OR is on a stable dose of low molecular weight heparin. Concurrent anti-platelet agents, daily prophylactic aspirin, or anticoagulation agents for atrial fibrillation allowed.

Title:	A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Completely Resected Stage IB-IIIA Non-Small Cell Lung Cancer (NSCLC) - IRB #08-08A
Treatments:	Bevacizumab, Cisplatin, Docetaxel, Gemcitabine, Vinorelbine tartrate
Disease Site:	Lung
Disease SubSite:	Non Small Cell Lung
Drug Provided:	Bevacizumab
Comments:
Eligibility:	Diagnosis of stage IB-IIIA (T2-3 N0, T1-3 N1, T1-3 N3) non-small cell lung cancer (NSCLC), Patients with stage IB disease must have tumors measuring equal to or less than 4 cm. Must have undergone complete resection of NSCLC within the past 6-12 weeks. Accepted types of resection include any of the following: Lobectomy , Sleeve lobectomy, Bilobectomy , Pneumonectomy, No resection by segmentectomy or wedge resection. Prior/Concurrent Therapy: See Disease Characteristics, Recovered from prior surgery, No prior systemic chemotherapy, No hormonal cancer therapy or radiotherapy as cancer treatment within the past 5 years, Prior surgery, biologic therapy, hormonal therapy, or radiotherapy for a malignancy diagnosed > 5 years prior to study entry that is now considered cured allowed, No major surgery or open biopsy within the past 28 days, No anticipated major surgery during course of treatment, No core biopsy within the past 7 days, Concurrent therapeutic anticoagulation therapy allowed, No concurrent aminoglycoside antibiotics.

Title:	Phase III Randomized Study of Four Weeks High Dose IFN-A2B in Stage T2B N0, T3A-BN0, T4A-B N0, and T1-4, N1A, 2A (microscopic) Melanoma - IRB# 03-24B
Treatments:	Interferon alpha-2b
Disease Site:	Melanoma
Disease SubSite:	Melanoma
Drug Provided:	-- none --
Comments:
Eligibility:	Pts. must have melanoma w/cutaneous origin; only pts. w/initial presentation of primary melanoma are eligible; pts. must not have clinically palpable lymphadenopathy; pts must meet one of the following criteria: 1)T3N0M0 - primary melanoma of 0-4 mm Breslow depth, clinically negative regional lymph nodes, pathologic status unknown 2) T3N0M0 - primary melanoma of 1.5-4 mm Breslow depth, histologically negative regional lymph nodes 3) T4N0M0 - primary melanoma > 4 mm Breslow depth 4) T1-4N1 - primary melanoma, one lymph node positive microscopically; pts. must complete all primary therapy (wide excision w/or w/o lymphadenectomy) and be randomized w/in 84 days of their wide excision.

Title:	An Intergroup Phase III Randomized Controlled Trial Comparing Melphalan, Prednisone and Thalidomide (MPT) Versus Melphalan, Prednisone and Lenalidomide (Revlimid(tm)) (MPR) in Newly Diagnosed Multiple Myeloma Patients Who Are Not Candidates for High-Dose Therapy - IRB# 08-95A
Treatments:	Asprin, Lenalidomide, Melphalan, Prednisone, Thalidomide
Disease Site:	Multiple myeloma
Disease SubSite:
Drug Provided:	Lenalidomide, Thalidomide
Comments:
Eligibility:	Newly diagnosed multiple myeloma (MM), meeting the following criteria: Bone marrow plasmacytosis with equal to or less than 10% plasma cells or sheets of plasma cells or biopsy proven plasmacytoma. Symptomatic disease with evidence of end-organ damage at initial diagnosis that prompted the initiation of therapy, including equal to or less than 1 of the following: Anemia, Hypercalcemia, Bone disease (lytic bone lesions or pathologic fracture), Renal dysfunction. No smoldering MM, defined by all of the following: Serum monoclonal protein equal to or less than 3 g/dL, Bone marrow plasma cells equal to or less than 10% or greater, Absence of anemia, hypercalcemia, lytic bone lesions, or renal dysfunction, No monoclonal gammopathy of undetermined significance, defined by all of the following: Serum monoclonal protein < 3 g/dL, Bone marrow plasma cells equal to or greater than 10%, Absence of anemia, hypercalcemia, lytic bone lesions, or renal dysfunction, Previously untreated for MM, Patients 18 to 64 years old must not be a candidate for autologous stem cell transplantation or have declined transplantation or other alternative treatment. Prior/Concurrent Therapy:See Disease Characteristics. No prior treatment for myeloma except for either of the following: Prednisone or dexamethasone treatment for myeloma for a duration of less than 4 weeks. Prednisone or dexamethasone in combination with thalidomide or lenalidomide for a duration of less than 2 weeks total. Concurrent bisphosphonates or growth factors (i.e., erythropoietin) for MM allowed. Concurrent localized radiation therapy is allowed for pain control at the physician’s discretion.

Title:	ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma - IRB # 06-106B
Treatments:	Sorafenib, Sunitinib
Disease Site:	Genitourinary
Disease SubSite:	Renal
Drug Provided:	Sorafenib, Sunitinib
Comments:	Baseline, after 2 cycles, after 4 cycles, and after 8 cycles. Send bill and MUGA report to the central office for each MUGA.
Eligibility:	Histologically or cytologically confirmed renal cell carcinoma, including any of the following subtypes: Clear cell carcinoma. Nonclear cell carcinoma. No collecting duct or medullary carcinomas. Meets 1 of the following risk categories: Intermediate high-risk disease . pT1b, G3-4 . pT2, G1-2 . pT2, G3-4 . pT3a, G1-2 (if pT3a is not due to adrenal involvement). Very high-risk disease . pT3a, G3-4 . pT3a, any G (if pT3a is due to adrenal involvement) . pTb or pTc, any G. pT4, any G. Any pT, any G, N+. Planning to start study treatment between 4-12 weeks after radical or partial nephrectomy . Underwent full surgical resection (i.e., radical or partial nephrectomy) by either open or laparoscopic technique within the past 3-10 weeks. Clinical evidence of lymph node positivity requires complete regional lymphadenectomy. All surgical specimens must have negative margins. Planning to undergo the above surgical resection AND meets all of the following criteria: Primary intact renal cell carcinoma, eligible for nephrectomy with curative intent . pT1b-4, N0 or any fully resectable N (i.e., N1-2), M0 disease by radiologic criteria, meeting any of the following criteria: Tumors equal to or less than 4 cm. Macroscopic fully resectable nodes. Surgically resectable renal vein thrombus. Surgically resectable inferior vena caval thrombus by radiologic criteria. Multifocal ipsilateral renal cell carcinoma allowed provided fully resectable and does not exceed inclusion criteria. No evidence of residual or metastatic renal cell cancer by chest, abdomen, and pelvic CT scan with oral and IV contrast within 4 weeks of randomization (after radical or partial nephrectomy). No history of distant metastases. Prior/Concurrent Therapy: Recovered from prior surgery . No prior anticancer therapy in either the adjuvant or neoadjuvant setting, including any of the following: Metastectomy for renal cell carcinoma.

Title:	Randomized Phase III Trial Comparing the Frequency of Major Erythroid Response (MER) to Treatment with Lenalidomide (Revlimid) Alone and in Combination with Epoetin Alfa (Procrit) in Subjects with Low- or Intermediate-1 Risk MDS and Symptomatic Anemia - IRB# 09-054B
Treatments:	Epoetin Alfa, Lenalidomide
Disease Site:	Myelodysplastic Syndrome
Disease SubSite:
Drug Provided:	Epoetin Alfa, Lenalidomide
Comments:
Eligibility:	Documented diagnosis of 1 of the following: Myelodysplastic syndromes (MDS) lasting => 3 months according to WHO criteria. Disease must not be secondary to treatment with radiotherapy, chemotherapy, and/or immunotherapy for malignant or autoimmune diseases. Non-proliferative chronic myelomonocytic leukemia (WBC <12,000/mm³). International prognostic scoring system category of low- or intermediate-1-risk MDS as determined by cytogenetic analysis. Patients with cytogenetic failure and < 10% marrow blasts are eligible. Must have symptomatic anemia with hemoglobin =< 9.5 g/dL* (transfusion independent or RBC transfusion-dependent [i.e., => 2 units/month]) within the past 8 weeks. [Note: *For transfusion independent patients, a minimum of 2 pre-transfusion or un-transfused hemoglobin values are required]. Must have failed treatment with an erythropoietic growth factor or have a low probability of response to rhu-erythropoietin, as defined by the following: Prior erythropoietin failure: requires a minimum trial of =>40,000 units epoetin alfa/week x 8 weeks or equivalent dose of darbepoetin alfa for 8 weeks with failure to achieve transfusion independence in dependent patients or a failure to achieve a => 2 g rise in hemoglobin sustained for => 4 weeks in transfusion independent patients. Low erythropoietin response profile: rhu-erythropoietin and epoetin alfa-naive patients receiving => 2 U pRBC/month and serum erythropoietin => 500 mU/mL in the 8 weeks prior to randomization for a hemoglobin =< 9.5 g/dL. Patients from SWOG institutions must be registered to protocol SWOG-9007. Prior/Concurrent Therapy: See Disease Characteristics. No prior lenalidomide. Prior thalidomide allowed. More than 8 weeks since prior cytotoxic chemotherapeutic agents, erythropoietin, or experimental agents (agents that are not commercially available) for the treatment of MDS. At least 28 days since prior non-transfusion therapy, except for prophylactic hydrocortisone to prevent transfus

Title:	A Double-Blind Phase III Trial of Doxorubicin and Cyclophosphamide followed by Paclitaxel with Bevacizumab or Placebo in Patients with Lymph Node Positive and High Risk Lymph Node Negative Breast Cancer - IRB# 08-40A
Treatments:	Bevacizumab, Cyclophosphamide, Doxorubicin
Disease Site:	Breast
Disease SubSite:	Node negative or positive
Drug Provided:	Bevacizumab
Comments:
Eligibility:	Histologically confirmed adenocarcinoma of the breast. Significant risk of distant recurrence based on =>1 of the following criteria: At least 1 axillary lymph node positive on routine histologic, examination (must be demonstrated by more than immunohistochemistry alone), Estrogen receptor (ER)-negative tumor=>1 cm , ER+ tumor=> 5 cm regardless of recurrence score, ER+ tumor =>1 cm but <5 cm with a recurrence score =>11, Patients enrolled on ECOG-PACCT-1 clinical trial are eligible, Has undergone definitive breast surgery within the past 29-84 days, including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, lumpectomy and axillary dissection, or lumpectomy and sentinel node biopsy.Surgical margins must be histologically free of invasive breast cancer and ductal carcinoma in situ. Resection margins positive for lobular carcinoma in situ allowed. Planned post-lumpectomy radiation therapy required, including any of the following: Whole breast radiation therapy after chemotherapy, Accelerated partial breast radiation therapy after chemotherapy , Accelerated partial breast radiation therapy prior to chemotherapy, Planned post-mastectomy radiation therapy required for patients with a primary tumor of > 5 cm or involvement of =>4 lymph nodes, No HER2/neu positive breast cancer (i.e., 3+ by immunohistochemistry or positive by fluorescent in situ hybridization [FISH]). No clinical evidence of inflammatory disease or fixed axillary nodes (N2) at diagnosis. May have synchronous bilateral breast cancer (diagnosed =<1 month) if the higher TNM stage tumor meets the eligibility criteria for this trial. Hormone receptor status known. Prior/Concurrent Therapy: See Disease Characteristics. More than 28 days since prior major surgery. Nonoperative biopsy not considered major surgery.

Title:	A Randomized Phase III Study Comparing 5-FU Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers - IRB# 06-44A
Treatments:	5 FU, Bevacizumab, Leucovorin, Oxaliplatin
Disease Site:	Gastrointestinal
Disease SubSite:	Colon
Drug Provided:	Bevacizumab, Oxaliplatin
Comments:	MEDICARE STUDY: Please alert billing staff
Eligibility:	Histologically confirmed adenocarcinoma of the colon. Stage II disease (T3-4, N0, M0) . At least 8 lymph nodes must have been evaluated . Distal extent of tumor must be => 12 cm from the anal verge by endoscopy or surgical examination. Has undergone surgical resection of the tumor between the past 28-60 days. No history of isolated, distant, or noncontiguous intra-abdominal metastases. Paraffin-embedded tumor specimen available. Prior/Concurrent Therapy:Biologic therapy: Not specified. Chemotherapy: Not specified. Endocrine therapy: Not specified. Radiotherapy: No prior radiotherapy for this cancer. Surgery: See Disease: haracteristics. More than 28 days since prior major surgery or open biopsy*. More than 7 days since prior core biopsy or other minor procedure except placement of a vascular access device*. [Note: *For patients with high-risk disease only]. Other: No prior systemic therapy for this cancer . No concurrent halogenated antiviral agents*.[Note: *For patients with high-risk disease only]

Title:	Program for the Assessment of Clinical Cancer Tests (PACCT-1): Trial Assigning Individualized Options for Treatment: The TAILORx Trial - IRB #06-82B
Treatments:	Chemotherapy, Hormonal Therapy
Disease Site:	Breast
Disease SubSite:	Node negative
Drug Provided:	-- none --
Comments:
Eligibility:	Eligibility Criteria and specifics are located in section 3 of the protocol.

Title:	Chemotherapy and Mindfulness Relaxation: A Randomized Trial at M. D. Anderson Cancer Center and M.D. Anderson Community Clinical Oncology Program - IRB# 08-70B
Treatments:	Mindfulness relaxation, Relaxing music, Standard Care
Disease Site:	Cancer control
Disease SubSite:
Drug Provided:	-- none --
Comments:	OPEN ONLY TO SWMC requires nurse credentialing at MD Anderson.
Eligibility:	Newly diagnosed malignant solid tumor. Undergoing at least 4 courses of chemotherapy. No evidence of distant metastatic disease. Prior/Concurrent Therapy: Biologic therapy, Not specified. Chemotherapy: See Disease Characteristics, No prior chemotherapy, Not planning to undergo an undefined number of chemotherapy regimens. Endocrine therapy: Not specified. Radiotherapy: Not specified. Surgery: Not specified. Other. Not planning to undergo immunotherapy (e.g., GMCSF, GCSF, IL2, interferon, etc.) <3 months after completion of chemotherapy.

Title:	Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for the Treatment and Prevention of Diarrhea in Patients with Metastatic Colorectal Cancer - IRB# 09-045A
Treatments:	Calcium aluminosilicate anti-diarrheal
Disease Site:	Cancer control
Disease SubSite:	Anti-diarrheal
Drug Provided:	Calcium aluminosilicate anti-diarrheal
Comments:
Eligibility:	Diagnosis of colorectal cancer, Metastatic disease, Scheduled to receive irinotecan hydrochloride alone or in combination with fluorouracil and/or biological therapy (e.g., cetuximab). No uncontrolled brain metastasis. Previously treated brain metastasis allowed. Prior/Concurrent Therapy: See Disease Characteristics, Prior treatment for metastatic disease allowed, More than 4 weeks since prior chemotherapy, More than 4 weeks since prior radiotherapy, No concurrent radiotherapy, No concurrent medication schedule that does not permit a 2-hour window between administration of calcium aluminosilicate anti-diarrheal (CASAD) and other medications.

Title:	Assessment of Patient Satisfaction with Participation in Phase II/III NCCTG Clinical Trials - IRB# 09-119B
Treatments:	Questionnaire booklets
Disease Site:	Quality Of Life
Disease SubSite:
Drug Provided:	-- none --
Comments:
Eligibility:	Enrollment on an NCCTG-sponsored clinical trial which has been designated as a parent study to N0392. The ability to complete the questionnaire booklets. Can be done with the aid of an interpreter, family member, or medical professional, if necessary. Contraindications: Cognitive impairment. If patient is able to complete the questionnaire, it will be assumed that cognitive impairment does not exist.

Title:	Phase I/II Evaluation of Everolimus (RAD001), Radiation and Temozolomide (TMZ) Followed by Adjuvant Temozolomide and Everolimus in Newly Diagnosed Glioblastoma - IRB# 10-039A
Treatments:	Everolimus, Radiation Therapy, Temozolomide
Disease Site:	Brain
Disease SubSite:	Glioblastoma multiforme
Drug Provided:	Everolimus
Comments:
Eligibility:	Histologically confirmed diagnosis of 1 of the following: Glioblastoma multiforme (grade 4 astrocytoma), Other grade 4 astrocytoma variants (e.g., giant cell), Gliosarcoma, Newly diagnosed disease, Some patients may be registered on protocol NCCTG-947252, No oligodendrogliomas or oligoastrocytomas. Prior/Concurrent Therapy: Inclusion criteria: At least 1 week, but no more than 6 weeks since prior surgical resection or biopsy, Must comply with antibiotic prophylaxis with either trimethoprim/sulfamethoxazole (daily or 3 times per week), oral dapsone (daily) combined with daily levofloxacin, or monthly pentamidine (inhaled or IV) combined with daily levofloxacin. Exclusion criteria: Prior chemotherapy for any brain tumor. Prior temozolomide or mTOR inhibitor therapies. Any prior cranial radiotherapy, Planned immunization with attenuated live vaccines during study period, At least 21 days since prior major surgery (excluding neurosurgical biopsy, resection of brain tumor, or treatment of immediate post-neurosurgical complication [e.g., intracranial hematoma]), Concurrent or prior treatment for this cancer with any other investigational agents, Concurrent enzyme-inducing anticonvulsants (EIACs) or other strong inducers of CYP3A4 (i.e., carbamazepine, phenytoin, phenobarbital/primidone, rifabutin, rifampin, or St. John's wort), Concurrent therapeutic doses of warfarin, Low molecular weight heparin is allowed, Concurrent systematic leukocyte growth factors (e.g., G-CSF or GM-CSF), except for the treatment of severe neutropenia, Concurrent drugs or substances known to inhibit or induce CYP3A, Other concurrent chronic treatment with immunosuppressive agents except Dexamethasone, Other concurrent anticancer agents.

Title:	Phase II Study of Panitumumab, Chemotherapy, and External Beam Radiation in Patients with Locally Advanced Pancreatic Cancer - IRB# 09-088A
Treatments:	5 FU, Capecitabine, Gemcitabine, Panitumumab, Radiation Therapy
Disease Site:	Gastrointestinal
Disease SubSite:	Pancreas
Drug Provided:	Panitumumab
Comments:
Eligibility:	Histologically or cytologically confirmed unresectable adenocarcinoma of the pancreas, Including subtotal resection and gross residual disease, No microscopic residual disease only, Measurable disease is not required, Disease is encompassable within standard radiotherapy fields for pancreatic cancer, No evidence of metastatic disease outside of the planned radiotherapy field, No cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin, No distant metastases (i.e., liver or lung metastases or peritoneal spread), No history or known presence of CNS metastases, Prior/Concurrent Therapy: More than 21 days since prior laparotomy, No prior anti-epidermal growth factor receptor (EGFR) antibody therapy (e.g., cetuximab), No prior small molecule EGFR inhibitors (e.g., gefitinib, erlotinib, or lapatinib), No prior radiotherapy that would overlap with planned radiotherapy fields, No prior or other concurrent chemotherapy, No prior or other concurrent biologic therapy , More than 4 weeks since prior and no concurrent or planned participation in another experimental drug study except studies with specific interventions intended to treat rashes associated with EGFR agents (e.g., N05C4), No concurrent enteral hyperalimentation, No concurrent chronic immunosuppressive agents (e.g., methotrexate, cyclosporine, or corticosteroids), No concurrent colony-stimulating factors during the first course of therapy, No other concurrent immunotherapy or radiotherapy

Title:	Randomized Phase II Trial of Panitumumab, Erlotinib, and Gemcitabine vs. Erlotinib and Gemcitabine in Patients with Untreated, Metastatic Pancreatic Adenocarcinoma - IRB# 10-011B
Treatments:	Erlotinib, Gemcitabine, Panitumumab
Disease Site:	Gastrointestinal
Disease SubSite:	Pancreas
Drug Provided:	Erlotinib, Panitumumab
Comments:
Eligibility:	Histologically or cytologically confirmed adenocarcinoma of the pancreas (ductal or undifferentiated) , Metastatic disease, No islet cell, acinar cell, or cystadenocarcinomas, No locally advanced disease. No history or known presence of CNS metastases. Prior/Concurrent Therapy: Recovered from prior therapy. More than 4 months since prior radiotherapy, immunotherapy, or biologic therapy. More than 4 weeks since prior and no elective or planned major surgery. More than 2 weeks since prior minor and no elective or planned surgery. More than 4 weeks since prior and no concurrent or planned participation in another experimental drug study except studies with specific interventions intended to treat rashes associated with EGFR agents (e.g., N05C4) . No prior cytotoxic chemotherapy for metastatic disease. Adjuvant chemotherapy for completely resected disease or chemoradiotherapy for locally advanced disease is allowed, provided it was administered > 6 months prior to study entry. Adjuvant chemotherapy must not have contained an EGFR inhibitor. Gemcitabine hydrochloride used as either a radiosensitizer or as maintenance therapy is allowed, provided more than 6 months have elapsed since the last day of treatment . No prior anti-EGFR antibody therapy (e.g., cetuximab) or treatment with small molecule EGFR inhibitors (e.g., gefitinib hydrochloride, erlotinib hydrochloride, or lapatinib). No concurrent chronic immunosuppressive agents (e.g., methotrexate, cyclosporine, or corticosteroids). No concurrent immunotherapy or radiotherapy. No other concurrent chemotherapy. No concurrent colony-stimulating factors during the first course of study therapy.

Title:	Randomized Phase II Trial of Capecitabine and Lapatinib with or without IMC-A12 in Patients with HER2 Positive Breast Cancer Previously Treated with Trastuzumab and an Anthracycline and/or a Taxane - IRB# 09-113A
Treatments:	Capecitabine, IMC-A12, Lapatinib
Disease Site:	Breast
Disease SubSite:
Drug Provided:	IMC-A12, Lapatinib
Comments:
Eligibility:	Histologically confirmed breast cancer, meeting one of the following criteria:Locally advanced disease (i.e., stage IIIB or IIIC [T4 primary tumor] disease) Metastatic disease. Disease progressed after treatment with regimens that included trastuzumab (Herceptin®) in combination with an anthracycline and/or a Taxane. Must have received 1-2 prior chemotherapy regimens in the neoadjuvant, adjuvant, or metastatic setting. One regimen must have included treatment with an anthracycline and/or a Taxane. Prior treatment with trastuzumab required unless there is a contraindication for trastuzumab treatment. HER2-positive disease, defined by any of the following: Validated IHC assay score of 3+ (defined as uniform, intense staining of > 30% of invasive tumor cells), Average HER2 gene copy number > 6, Gene amplified (HER2:D17Z1 ratio > 2.20). Measurable disease according to RECIST criteria. No evidence of active brain metastases, including leptomeningeal involvement. CNS metastasis controlled* by prior surgery and/or radiotherapy is allowed. [Note: *To be considered controlled, there must have been no symptoms for at least 2 months or no evidence of progression prior to study entry AND corticosteroid therapy must have been discontinued]. Hormone receptor status not specified.

Title:	The Use of Wisconsin Ginseng (panax quinquefolius) to Improve Cancer-Related Fatigue: A Randomized, Double-Blind, Placebo-Controlled Phase III Study - IRB# 09-01A
Treatments:	Wisconsin Ginseng
Disease Site:	Cancer control
Disease SubSite:	Fatigue
Drug Provided:	Wisconsin Ginseng
Comments:
Eligibility:	Diagnosis of histologically or cytologically proven cancer within the past 2 years. Currently undergoing curative intent therapy (including anti-hormonal therapies such as tamoxifen or leuprolide) or completed curative intent therapy. Must have completed >1 course of chemotherapy or targeted therapy or > 1 week of radiation therapy. Not planning to start new or complete cancer therapy during study. History of cancer-related fatigue as defined by an average score of => 4 over the past 30 days on the numeric analogue scale (0–10). Experiencing fatigue for > 1 month. No known brain metastasis or primary CNS malignancy. Prior/Concurrent Therapy: See Disease Characteristics. More than 4 weeks since prior major surgery including any procedure that requires general anesthetic. Concurrent erythropoietin agents for anemia allowed. No prior use of ginseng capsules for fatigue. Prior teas or beverages containing ginseng are allowed. No concurrent over-the-counter herbal/dietary supplement marketed for fatigue or energy (e.g., products containing any type of ginseng, rhodiola rosea, high doses of caffeine, guarana, or anything called an “adaptogen”). No concurrent pharmacologic agent that specifically treats fatigue including, but not limited to, psychostimulants or antidepressants except antidepressants to treat conditions other than fatigue (e.g., hot flashes) provided patient has been on a stable dose for =>1 month and plans to continue for =>1 month. No concurrent chronic systemic steroids (including as part of cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisolone [CHOP] therapy or any regular cancer treatment) except as prophylaxis for nausea and vomiting. No concurrent full dose anticoagulant therapy. 1 mg/day of coumadin for preventing catheter clots allowed. No concurrent monoamine oxidase inhibitors. No concurrent single agent on a blinded placebo controlled treatment trial.

Title:	Paclitaxel-Associated Acute Pain Syndrome Natural History Study - IRB# 09-032A
Treatments:	-- none --
Disease Site:	Cancer control
Disease SubSite:	Paclitaxel-Associated Acute Pain Syndrome
Drug Provided:	-- none --
Comments:	Arm B of this study is closed to accrual for the general patient population, but will remain open to minority accrual only. Arm C of this study is closed to accrual for the general patient population, but will remain open to minority accrual only. Arms A and D will remain open to the general patient population, per study design. Research blood draws provided.
Eligibility:	Diagnosis of cancer, Planning to receive paclitaxel (excluding paclitaxel albumin-stabilized nanoparticle formulation [nab-paclitaxel]) according to one of the following dosing schedules: At least 175 mg/m2 at 2-4 week intervals (course duration of 2, 3, or 4 weeks, respectively), 70-90 mg/m2 weekly (3 out of 4 weeks allowed). Prior/Concurrent Therapy: See Disease Characteristics. No prior paclitaxel or neurotoxic chemotherapy drugs, including other taxanes, platinum agents, vinca alkaloids, or epothilones. No concurrent neutrophil colony-stimulating factor therapy. Patient Characteristics: ECOG performance status 0-1, Life expectancy > 6 months, Able to complete questionnaires (alone or with assistance), willing to provide required biological specimens, No prior or concurrent peripheral neuropathy (from diabetes or other causes), No prior or concurrent fibromyalgia.

Title:	Phase III, Randomized, Placebo-controlled, Double-Blind Trial of Flaxseed for the Treatment of Hot Flashes - IRB# 09-101A
Treatments:	Flaxseed bar
Disease Site:	Cancer control
Disease SubSite:
Drug Provided:	Flaxseed bar
Comments:	This study is permanently closed to accrual for the general patient population, but will remain open to minority accrual only, effective Friday, December 18, 2009. Minority patient entry only will be allowed after 4:30 p.m. CST Thursday, December 17, 2009. The accrual objective for the general population has been met. Patients currently on study should be followed according to the protocol.
Eligibility:	At least 4 weeks since prior and no concurrent or planned androgens, estrogens, or progestational agents . Tamoxifen, raloxifene, or aromatase inhibitors are allowed provided the patient has been on a constant dose for => 4 weeks and is not expected to stop the medication during study treatment. No concurrent treatment with other anti-cancer therapies of any kind except for trastuzumab or endocrine therapies. No concurrent (=< 7 days prior to registration) or planned use of other agents for treating hot flashes (i.e., gabapentin, clonidine, antidepressants, estrogen treatment, megestrol acetate, or Bellergal) . Stable dose of vitamin E (as a general vitamin supplement) allowed provided it is =< 800 IU/day, it was started >30 days before study initiation, and is to be continued through study period. Patients who have been using antidepressants for mood and have been on a stable dose for over a month and meet the eligibility criteria for hot flash frequency and duration are eligible. No concurrent anticoagulants or anti-platelets (1 mg of coumadin for central line patency allowed). Aspirin allowed (=< 81 mg). No concurrent anti-hypertensives. No other concurrent herbal supplements for any reason, including soy and soy supplements (i.e., powders, pills, or milk).

Title:	A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer - IRB# 05-53A
Treatments:	Partial Breast Irradiation, Whole Breast Irradiation
Disease Site:	Breast
Disease SubSite:
Drug Provided:	-- none --
Comments:	Investigators must be credentialed in order to enroll participants
Eligibility:	Histologically confirmed ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast . Stage 0, I, or II disease , Stage II tumors must be =< 3 cm, Gross disease must be unifocal , Microscopic multifocality allowed provided total pathological tumor size is =< 3 cm, No proven multicentric carcinoma in more than 1 quadrant or separated by = 4 cm , No non-epithelial breast malignancies (e.g., sarcoma or lymphoma), Prior axillary staging required for patients with invasive breast cancer, including 1 of the following: Sentinel node biopsy alone (if sentinel node is negative) , Sentinel node biopsy followed by axillary dissection or sampling with => 6 axillary nodes (if sentinel node is positive) , Axillary dissection alone with => 6 axillary nodes, No more than 3 positive axillary nodes , No axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension , No positive non-axillary sentinel nodes (intramammary nodes are staged as axillary nodes). No palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor. Must have undergone lumpectomy. Resected margins histologically free of tumor. Re-excision of surgical margins allowed. Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast reference volume =< 30% based on postoperative CT scan. Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging procedure) within the past 42 days. No suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign. No Paget’s disease of the nipple. No history of invasive breast cancer or DCIS, Prior lobular carcinoma in situ treated by surgery alone allowed. No synchronous bilateral invasive or non-invasive breast cancer.

Title:	A Phase III Clinical Trial Comparing Trastuzumab Given Concurrently with Radiation Therapy and Radiation Therapy Alone for Women with HER2-Positive Ductal Carcinoma In Situ Resected by Lumpectomy - IRB# 09-023B
Treatments:	HER2 Testing, Radiation Therapy, Trastuzumab
Disease Site:	Breast
Disease SubSite:	DCIS
Drug Provided:	HER2 Testing, Trastuzumab
Comments:
Eligibility:	Histologically confirmed ductal carcinoma in situ (DCIS), Mixed DCIS and lobular carcinoma in situ (LCIS) allowed, HER2 receptor-positive as determined by central testing. Must have undergone resection by lumpectomy and meets the following criteria: Margins of the resected specimen must be histologically free of DCIS (re-excision to obtain clear margins allowed), No more than 120 days since the last surgery for excision of DCIS (lumpectomy or re-excision of lumpectomy margins), None of the following allowed: Patients who require mastectomy, Invasive (including microinvasion staged as T1mic) breast cancer (DCIS “suspicious” for microinvasion, but not confirmed, allowed), Nodal staging of pN1 (including pN1mi) (axillary staging not required), DCIS present in more than one quadrant (multicentric), Masses or clusters of calcification that are clinically or mammographically suspicious unless biopsied and proven to be benign, Contralateral breast cancer (including DCIS), History of breast cancer, including DCIS (history of LCIS allowed). Hormone receptor status: Estrogen receptor and/or progesterone receptor-positive or –negative, Must submit tumor block for correlative studies. Prior/Concurrent Therapy: See Disease Characteristics, No prior whole or partial breast irradiation, No prior anthracycline chemotherapy for any malignancy, No investigational agents within the past 30 days, No other cancer therapy until the time of first cancer recurrence or second primary cancer.

Title:	CIRG (TRIO) 011/NSABP B-44-I/BO20906: A Multicenter Phase III Randomized Trial of Adjuvant Therapy for Patients with HER2-Positive Node-Positive or High Risk Node-Negative Breast Cancer Comparing Chemotherapy Plus Trastuzumab with Chemotherapy Plus Trastuzumab Plus Bevacizumab - IRB# 08-41A
Treatments:	Bevacizumab, Carboplatin, Dexamethasone, Docetaxel, Trastuzumab
Disease Site:	Breast
Disease SubSite:
Drug Provided:	Bevacizumab
Comments:	INVESTIGATORS MUST BE REGISTERD TO ENROLL PATEINTS IN THIS TRIAL. Bevacizumab, urine tests, scheduled echocardiograms/MUGA scans, and HER2 test provided.
Eligibility:	Life expectancy of at least 10 years, excluding their diagnosis of breast cancer. Women who have had breast reconstruction utilizing tissue expanders must be in agreement with not having expansion performed within 2 weeks before the first dose of bevacizumab, during bevacizumab therapy, and until 6 weeks following the last dose of Bevacizumab. Women of reproductive potential must agree to use an effective non-hormonal method of contraception (for example condoms, some intrauterine devices, diaphragms, vasectomized partner, or abstinence) during therapy and for at least 6 months after the last dose of bevacizumab and/or trastuzumab. Submission of tumor samples from the breast surgery for central HER2 testing is required for all patients prior to enrollment in the BETH Trial. Signed and dated IRB/EC-approved consent. ECOG performance status of 0 or 1. The tumor must be unilateral invasive adenocarcinoma of the breast on histologic examination. The breast cancer must be HER2-positive based on test results as follows: Local testing (if available) should demonstrate that the tumor is IHC 2+ or 3+ or is considered to be HER2-positive for gene amplification by FISH, CISH, or other in situ hybridization (ISH) method. (If local ISH test results are considered equivocal, the tumor can be submitted for central HER2 testing.) Central testing (a requirement for ALL patients) must demonstrate that the tumor is HER2-positive which is defined as FISH-positive and/or IHC 3+. All of the following staging criteria (according to the 6th edition of the AJCC Cancer Staging Manual) must be met: By pathologic evaluation, primary tumor must be pT1-3; By pathologic evaluation, ipsilateral nodes must be pN0, pN1 (pN1mi, pN1a, pN1b, pN1c), pN2a, pN3a, or pN3b. If pN0, at least one of the following criteria must be met: Pathologic tumor size > 2.0 cm; ER negative and PgR negative; Histologic and/or nuclear grade 2 (intermediate) or 3 (high); or Age < 35 years.

Title:	A Clinical Trial Comparing Preoperative Radiation Therapy and Capecitabine with or without Oxaliplatin with Preoperative Radiation Therapy and Continuous Intravenous Infusion of 5-Fluorouracil with or without Oxaliplatin in the Treatment of Patients with Operable Carcinoma of the Rectum - IRB# 04-138B
Treatments:	5-Fluorouracil, Capecitabine, Oxaliplatin, Radiation Therapy
Disease Site:	Gastrointestinal
Disease SubSite:	Rectal
Drug Provided:	Capecitabine, Oxaliplatin
Comments:	MEDICARE STUDY: PLEASE ALERT BILLING STAFF
Eligibility:	Diagnosis of adenocarcinoma of the rectum. Diagnosis obtained within the past 42 days by a biopsy technique which leaves the major portion of the tumor intact . Stage II (T3-4, N0 [N0is defined as all imaged lymph nodes <1.0 cm]) OR stage III (T1-4, N1-2 [with the definition of a clinically positive lymph node being any node =>1.0 cm], Clinically staged by transrectal ultrasound and CT scan or MRI. Tumor palpable by digital rectal exam OR accessible by proctoscope or sigmoidoscope. Distal border of the tumor must be located < 12 cm from the anal verge. Tumor amenable to curative resection*, [Note: *Curative resection can include pelvic exenteration], No history of invasive rectal malignancy, regardless of disease-free interval, No other rectal cancers (i.e., sarcoma, lymphoma, carcinoid, squamous cell carcinoma, or cloacogenic carcinoma), No synchronous colon cancer, No clear indication of involvement of the pelvic side walls by imaging, No evidence of metastatic disease, Prior/Concurrent Therapy: Biologic therapy: No concurrent prophylactic filgrastim (G-CSF) or sargramostim (GM-CSF), Radiotherapy: No prior pelvic radiotherapy, Surgery: See Disease Characteristics ;Other: No prior therapy for this cancer , More than 4 weeks since prior participation in any investigational drug study, No concurrent halogenated antiviral agents (e.g., sorivudine or brivudine).

Title:	A Phase II Clinical Trial of Four Cycles of Doxorubicin and Cyclophosphamide Followed by Weekly Paclitaxel Given Concurrently with Pazopanib as Neoadjuvant Therapy Followed by Postoperative Pazopanib for Women with Locally Advanced Breast Cancer - IRB #09-22A
Treatments:	Cyclophosphamide, Doxorubicin, Paclitaxel, Pazopanib
Disease Site:	Breast
Disease SubSite:	Locally advanced or inflammatory
Drug Provided:	Pazopanib
Comments:	Investigators must be on the approval list below in order to enroll patients on this study.
Eligibility:	Prior to study entry, the local pathology department must have agreed to release the tumor block from the diagnostic biopsy sample. (Note: The tumor block from the diagnostic biopsy sample must be submitted within 60 days after study entry.) Patients must be female, Patients must be => 18 years old. The ECOG performance status must be 0 or 1 (see Appendix A), Patients must have the ability to swallow oral medication. The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy or limited incisional biopsy. Patients must have ER analysis performed on the primary tumor prior to randomization. If ER analysis is negative, then PgR analysis must also be performed. Patients are eligible with either hormone receptor-positive or hormone receptor-negative tumors. Patients must have clinical stage IIIA, IIIB, or IIIC disease (see Appendix B) with a mass in the breast or axilla measuring =>2.0 cm by physical exam, unless the patient has inflammatory breast cancer, in which case measurable disease by physical exam is not required. (Clinical staging should be based on the assessment by physical exam.

Title:	A Phase III Prospective Randomized Trial of Dose-Escalated Radiotherapy With or Without Short-Term Androgen Deprivation Therapy for Patients With Intermediate-Risk Prostate Cancer - IRB# 10-041B
Treatments:	Hormonal Therapy, Radiation Therapy
Disease Site:	Genitourinary
Disease SubSite:	Prostate
Drug Provided:	-- none --
Comments:
Eligibility:	Histologically confirmed adenocarcinoma of the prostate diagnosed within the past 6 months and at intermediate-risk for recurrence by meeting =>1 of the following criteria: Gleason score >7, PSA >10, and =< 20 ng/mL, Baseline serum PSA value performed within 60 days with an FDA-approved assay (e.g., Abbott, Hybritech) . Baseline PSA must not be obtained during any of the following time frames:10-day period after prostate biopsy, after initiation of androgen-deprivation therapy, or within the past 30 days after discontinuation of finasteride (90 days for dutasteride). Clinical stage T2b or T2c disease. No patients with all 3 intermediate-risk factors who also have => 50% of the number of their biopsy cores positive for cancer . The percentage of biopsy cores involved will only be considered with respect to eligibility for those patients with all 3 of the above risk factors (i.e., patients with one or two of the above risk factors are eligible irrespective of the percentage of biopsy cores involved). Clinically negative lymph nodes as established by imaging (pelvic and/or abdominal CT scan or MRI), nodal sampling, or dissection within the past 60 days (required for patients with 2-3 risk factors). Abdominal imaging not required for a single intermediate-risk factor (these studies may be obtained at the discretion of the treating physician). Lymph nodes that are equivocal or questionable by imaging allowed without biopsy if nodes =<1.5 cm. Any node >1.5 cm on imaging requires a negative biopsy. No evidence of bone metastases on bone scan within the past 60 days. Bone scan not required for patients with a single intermediate-risk factor (scan may be obtained at the discretion of the treating physician). Equivocal bone scan findings allowed if plain film x-rays negative for metastasis.

Title:	Phase III Double-blind Placebo-Controlled Trial of Conventional Concurrent Chemoradiation And Adjuvant Temozolomide Plus Bevacizumab Versus Conventional concurrent Chemoradiation and adjuvant Temozolomide In Patients with Newly Diagnosed Glioblastoma - IRB# 09-062B
Treatments:	Bevacizumab, RT, Temozolomide
Disease Site:	Brain
Disease SubSite:	Glioblastoma multiforme
Drug Provided:	Bevacizumab
Comments:	PPMC, PSVMC and Northwest Cancer Specialist - Vancouver are site approved to enroll both the facility questionnaire and 3D conformal RT. Credentialing has been completed.
Eligibility:	Histologically confirmed glioblastoma or gliosarcoma. WHO grade IV disease. Tumor must have a supratentorial component. Has undergone partial or complete surgical resection of tumor within the past 3-5 weeks. Diagnosis must be made by surgical excision (not by stereotactic biopsy). No significant postoperative hemorrhage, defined as > 1 cm diameter of blood in the tumor cavity by MRI or CT scan. Has => 1 block of tumor tissue of sufficient size available for analysis of MGMT status and determination of molecular profile. At least 1 cm³ of tissue composed primarily of tumor must be present. No CUSA (Cavitron ultrasonic aspirator)-derived material. No recurrent or multifocal malignant glioma. No metastases detected below the tentorium or beyond the cranial vault. Prior/Concurrent Therapy: Recovered from prior surgery. No prior chemotherapy or radiosensitizers for cancer of the head and neck region. Prior chemotherapy for a different cancer is allowed. No prior temozolomide or Bevacizumab. No prior Gliadel wafers or any other intratumoral or intracavitary treatment. No prior radiotherapy to the head and neck (except for T1 glottic cancer) resulting in overlap of radiotherapy fields. More than 28 days since prior major surgical procedure or open biopsy other than craniotomy for tumor resection. More than 30 days since prior and no concurrent treatment on another therapeutic clinical trial. No concurrent growth factors to induce elevations in neutrophil count for the purposes of administration of temozolomide on the scheduled dosing interval; to allow treatment with temozolomide at a higher dose; or to avoid interruption of the treatment during concurrent radiotherapy. No concurrent erythropoietin. No concurrent tumor debulking surgery, other chemotherapy, immunotherapy, biologic therapy, or additional stereotactic boost radiotherapy. No other concurrent investigational drugs during the "blinded phase” of the study. Concurrent full-dose anticoagulants (e.g.,

Title:	Chemoradiation as Adjuvant Treatment for Patients with Resected Head of Pancreas Adenocarcinoma - IRB# 10-042B
Treatments:	5 FU, Capecitabine, Erlotinib, Fluoropyrimidine, Gemcitabine, RT
Disease Site:	Gastrointestinal
Disease SubSite:	Pancreas
Drug Provided:	Erlotinib
Comments:
Eligibility:	Histologically confirmed primary adenocarcinoma of the pancreatic head, neck, or uncinate process. Intraductal papillary mucinous neoplasm or invasive adenocarcinoma allowed. No non-adenocarcinoma, adenosquamous carcinoma, islet cell (neuroendocrine) tumor, cystadenoma, cystadenocarcinoma, carcinoid tumor, duodenal carcinoma, distal bile duct tumor, or ampullary carcinoma. Pathologic stage T1-3, N0-1, M0 disease according to AJCC 6th edition. Has undergone a potentially curative resection (i.e., removal of all gross tumor) involving a classic (Whipple) or a pylorus preserving pancreaticoduodenectomy within the past 21-56 days. Operative report must contain a statement from the surgeon explicitly detailing that a total gross excision of the primary tumor was achieved. Pathology report must include documentation of margin status, size of the tumor, and status of the 3 major surgical margins (bile duct, pancreatic parenchyma, and retroperitoneal [uncinate]). Post-resection serum CA19-9 =<180 IU/L. Tumor tissue block and peripheral blood samples must be submitted to the study's central tumor bank for correlative studies. No recurrent pancreatic cancer. Prior/Concurrent Therapy: See Disease Characteristics. No prior systemic chemotherapy for pancreatic cancer. Prior chemotherapy for a different cancer allowed. No prior total pancreatectomy, distal pancreatectomy, or central pancreatectomy. No prior radiotherapy to the region of the study cancer that would result in overlap of radiotherapy fields. Concurrent highly active antiretroviral treatment (HAART) allowed.

Title:	Central Lymphoma Repository Tissue Procurement Protocol - IRB# 89-058B
Treatments:	-- none --
Disease Site:	Cancer control
Disease SubSite:	Tissue repository
Drug Provided:	-- none --
Comments:	SWOG (Any other reimbursement for the submission of specimens to this banking protocol will be made based on the requirements of each associated treatment protocol).
Eligibility:	For patients registered to a currently active Southwest Oncology Group-coordinated treatment protocol for previously untreated non-Hodgkin's lymphoma.

Title:	Central Lymphoma Serum Repository Protocol - IRB# 90-047B
Treatments:	Tissue repository
Disease Site:	Lymphoma
Disease SubSite:	Serum Repository
Drug Provided:	-- none --
Comments:	SWOG (Any other reimbursement for the submission of specimens to this banking protocol will be made based on the requirements of each associated treatment protocol).
Eligibility:	For patients registered to a currently active Southwest Oncology Group-coordinated treatment protocol for previously untreated non-Hodgkin's lymphoma.

Title:	Cytogenetic Studies in Leukemia Patients - IRB# 91-050B
Treatments:	Tissue repository
Disease Site:	Leukemia
Disease SubSite:	Cytogenetic Study
Drug Provided:	-- none --
Comments:
Eligibility:	Cytogenetic studies in Leukemia patients registered on SWOG 8326, 8600, 8612, 9034, 9108, or any leukemia treatment protocol

Title:	Central Lymphoma Repository Tissue Procurement Protocol for Relapse or Recurrent Disease, Ancillary - IRB# 93-016B
Treatments:	Tissue repository
Disease Site:	Lymphoma
Disease SubSite:	Tissue repository
Drug Provided:	-- none --
Comments:
Eligibility:	For patients with prior registration to a Southwest Oncology Group-coordinated treatment protocol for previously untreated non-Hodgkin's lymphoma.

Title:	Phase III Trial of Continuous Schedule AC+G Vs. Q 2 Week Schedule AC, Followed by Paclitaxel Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-Operative Adjuvant Therapy in Node-Positive or High-Risk Node Negative Breast Cancer - IRB# 04-068B
Treatments:	AC, Cyclophosphamide, Doxorubicin, Filgrastim, Paclitaxel, Trimethoprim sulfa
Disease Site:	Breast
Disease SubSite:	High Risk Node Neg or Node Positive
Drug Provided:	G-CSF
Comments:	Growth factor support with G-CSF(provided). Arms that require Peg-G: Peg G is not provided.SWOG (Automatic Specimen Reimbursement): Specimen Tracking System
Eligibility:	Histologically confirmed diagnosis of operable Stage I, II, or III invasive breast carcinoma with known estrogen or progesterone receptor status; Patients with T4 tumors are not eligible; Patients with bilateral synchronous breast cancer diagnosed within 1 month of each other are eligible; Patients must be high risk by meeting one of the following criteria: (1) tumor >/= 2 cm in greatest diameter (includes both invasive & intraductal component; (2) tumor >/= 1 cm in diater and either ER-/PgR- OR ER+ or PgR+ with a Genomic Health Recurrence Score of >/= 26; (3) one of more axillary or intramammary nodes are positive; Either modified radical mastectomy or local excision of all tumors plus an axillary lymph node dissection or sentinel node resection prior to registration; Patients must have at least 6 axillary or intramammary lymph nodes sampled, with the exception of patients who have a sentinel node procedure with all sampled nodes being uninvolved by malignancy; Patients must be registered within 84 days from final surgical procedure; No prior cytotoxic chemotherapy or chemotherapy with anthracycline, anthrcenedione, or taxane; Co-enrollment in S0230, NSABP B-39, IBCSG 24-02 (SOFT), and IBCSG 25-02 (TEXT) are allowed; No prior radiation therapy except for partial breast irradiation (PBI); PBI must be completed at least 2 wks prior to registration; RT for prior DCIS ok if done 2 wks before registration; No clinical diagnosis for congestive heart failure or angina pectoris; If history of hypertension or age >=60 years, MUGA, echocardiogram scan, or cardiac catheterization must be performed within 42 days prior to registration and LVEF %>= ILLN; Serum creatinine and bilirubin <= IULN; alkaline phosphatase <= 2x IULN; SGOT/SGPT <= 2x IULN; ANC >= 1, 2000; platelet count >= 100,000; No nursing or pregnant women.

Title:	Myeloma Specimen Repository Protocol, Ancillary - IRB# 04-112B
Treatments:	-- none --
Disease Site:	Multiple myeloma
Disease SubSite:	Myeloma Specimen Repository
Drug Provided:	-- none --
Comments:	SWOG (Reimbursement for the submission of specimens to this banking protocol will be made based on the requirements of each associated treatment protocol).
Eligibility:	Pts must be currently registered on a Southwest Oncology Group treatment study (SWOG or Intergroup) for multiple myeloma, smoldering myeloma, Waldenstrom's macroglobulinemia, monoclonal gammopathy of undetermined significance, or amyloidosis. Pts who are already enrolled on active SWOG treatment protocols are eligible for this study. A minimum of 3 ml of bone marrow aspirate and at least one tube of blood (preferably two tubes of blood), will be collected from each pt. Pretreatment specimens must be submitted to be eligible for this study. A pt may be registered on this protocol only once. If a pt on this study subsequently enters another treatment protocol related to this study, then specimens can be submitted according to the procedures of this protocol, and the pt need not be registered again on this study.

Title:	Molecular Epidemiology Case-Series Study of Non-Small Cell Lung Cancer in Smoking and Non-Smoking Women and Men - IRB #06-36B
Treatments:	-- none --
Disease Site:	Cancer control
Disease SubSite:	Tissue repository
Drug Provided:	-- none --
Comments:	SWOG (Automatic Specimen Reimbursement): Specimen Tracking System)
Eligibility:	Pts must have newly diagnosed, primary, histologically confirmed Stage I, II or IIIB (T4 or N3, excluding patients w/ malignant pleural effusion) NSCLC; Pts w/effusion are eligible if: a)fluid tapped is benign cytology and all physicians concur that it is from a benign etiology, b) fluid present after mediastinoscopy or thoracotomy, but not before, c) fluid deemed too small to tap under CT or U/S guidance; May be registered concurrently to a therapeutic study but not required to be on a therapeutic study; Must have tumor block/slides available and willing to provide tissue and blood sample for testing; Must have specific tissue specimens available as outlined in Section 4.2; Able and willing to complete the Lung Cancer Epidemiology Questionnaire and able to read and understand English; Must be identified and registered w/in 120 days of diagnosis; Must be willing to provide smoking history; Pts must not have diagnosis by cytology alone; Pts must not have malignant pleural effusion; Pts must not have other prior malignancy except for treated basal cell (or squamous cell) skin ca or in situ cervical ca; Pts must not have prior systemic chemotherapy or RT for cancer; Pts must not have pericardial effusions. NOTE: Pts registered concurrently to therapeutic trials must have blood and tissue obtained PRIOR to administration of ANY therapeutic agent(s)

Title:	A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who Have Elevated Circulating Tumor Cell Levels at First Follow-Up Assessment - 07-34A
Treatments:	-- none --
Disease Site:	Breast
Disease SubSite:	Metastatic breast
Drug Provided:	-- none --
Comments:	SWOG (Automatic Specimen Reimbursement): Specimen Tracking System for the following: blood draw. Arm A: dependent on based CTC count a one time payment may occur for follow up of these patients. See specifics in funding memo. Arms B, C1, and C2: A one time payment per patients to offset collection of shipment and serum via SWOG (Automatic Specimen Reimbursement): Specimen Tracking System.
Eligibility:	Histologically confirmed breast cancer . Clinical evidence of metastatic disease (stage IV disease). Newly metastatic disease OR progressive metastatic disease while on hormonal therapy. Meets 1 of the following criteria: Measurable disease, Bone-only disease* [Note: *Patients with nonmeasurable disease that does not include bone are not eligible] HER-2 status determined by immunohistochemistry (IHC) or fluorescent in situ hybridization (FISH) assay. HER-2 positivity is defined as IHC 3+ or FISH+ . If IHC is indeterminate (2+), FISH must be performed to classify disease. Planning to undergo first-line chemotherapy for metastatic disease. Patients with brain metastases must have stable disease for > 90 days after completion of prior radiotherapy to the brain. No leptomeningeal disease. Hormone receptor status not specified. Prior/Concurrent Therapy: See Disease Characteristics Prior hormonal therapy, bisphosphonate therapy, trastuzumab (Herceptin®), and/or bevacizumab for metastatic disease allowed. Any number of exogenous hormonal therapies for metatstatic disease and/or as adjuvant therapy allowed. At least 1 year since prior adjuvant chemotherapy. At least 2 weeks since prior minor surgery and recovered. At least 4 weeks since prior major surgery and recovered. No prior chemotherapy for metastatic disease. Concurrent hormonal therapy and/or bisphosphonate therapy allowed. Concurrent trastuzumab and/or bevacizumab allowed.

Title:	Phase III Prospective Randomized Comparison of Depot Octreotide plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients - IRB# 09-072B
Treatments:	Bevacizumab, Interferon alpha-2b, Octreotide
Disease Site:	Gastrointestinal
Disease SubSite:
Drug Provided:	Bevacizumab
Comments:	01/26/10: Registration Step 2 (SPECT Substudy) is temporarily closed to accrual effective immediately, due to a recall and lack of supply of Octreoscan™ kits. This substudy is described in Sections 5.31-5.33, Section 15.1.b, and Appendix 19.6 of the protocol. Until the substudy re-opens, institutions are NOT required to seek additional patient consent for the substudy. NOTE: The treatment study (Registration Step 1) remains open to accrual.
Eligibility:	Diagnosis of unresectable metastatic or locally advanced, low- or intermediate-grade neuroendocrine carcinoma, including the following subtypes: Carcinoid tumor, low-grade or well differentiated neuroendocrine carcinoma. Atypical carcinoid tumor, intermediate-grade or moderately differentiated neuroendocrine carcinoma. High-risk disease as defined by at least one of the following: Progressive disease. Refractory carcinoid syndrome while receiving octreotide acetate (i.e., defined by >2 flushing episodes/day or >4 bowel movements/day). Atypical histology and more than 6 lesions. Metastatic colorectal carcinoid tumor. Patients with metastatic cecal or appendiceal carcinoid tumor are not eligible unless they fit other mentioned high-risk features. Metastatic gastric carcinoid tumor. Measurable disease. Patients with poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid tumor, or goblet cell carcinoid tumor are not eligible.

Title:	A Phase II Trial of the Combination of OSI-774 (Erlotinib; NSC-718781) and Bevacizumab (Rhumab VEGF; NSC-704865) in Never-Smokers with Stage IIIB and IV Primary NSCLC Adenocarcinomas - IRB# 07-148A
Treatments:	Bevacizumab, OSI-774
Disease Site:	Lung
Disease SubSite:	Non Small Cell Lung
Drug Provided:	Bevacizumab, OSI-774
Comments:	SWOG (Automatic Specimen Reimbursement): Specimen Tracking System
Eligibility:	Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). Adenocarcinoma, No component of squamous cell carcinoma present, Incompletely resected or unresectable disease, Stage IIIB or IV disease as defined below: Selected stage IIIB disease, T4 (secondary to malignant pleural effusion only), Any N, M0, Stage IV disease, Any T, Any N, M1 (distant metastases present), Recurrent lung cancer in a separate lobe after resection or radiotherapy within the past 5 years OR multifocal lesions in > 1 lobe considered stage IV disease, New lesions occurring => 5 years after resection may be considered a separate primary cancer and are not allowed if this is the only focus of lung cancer, Measurable and/or nonmeasurable disease by CT scan, positron emission tomography scan, or MRI, Disease must be present outside a previous radiotherapy field OR a new lesion must be inside the port , Measurable disease must be assessed within the past 28 days, Nonmeasurable disease must be assessed within the past 42 days, Pleural effusions, ascites, and laboratory parameters are not acceptable as the only evidence of disease, Must be a lifelong nonsmoker (<100 cigarettes in lifetime).

Title:	A Prospective Observational Multicenter Cohort Study to Assess the Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment - IRB# 09-013A
Treatments:	-- none --
Disease Site:	Cancer control
Disease SubSite:	Bone Metastases
Drug Provided:	-- none --
Comments:
Eligibility:	Bone metastasis from multiple myeloma, solid tumor, other malignancy where bisphosphonate is indicated; planned treatment with zoledronic acid; < / = 3 doses IV ibandronate, pamidronate or zoledronic acid in past 3 years for osteopenia or osteoporosis; < / = 90 days IV ibandronate, pamidronate, or zoledronic acid for metastatic bone disease, Zubrod PS 0-3; willing to provide information regarding smoking history, alcohol consumption, pain assessments; willing to undergo dental assessments per protocol; willing to provide access to prior and future dental information; participation in other therapeutic or non-therapeutic trials is o.k.

Title:	Randomized Placebo-controlled Trial of Acetyl-L-Carnitine (ALC) For the Prevention of Taxane Induced Neuropathy, Phase III - IRB # 09-095B
Treatments:	Acetyl L-Carnitine
Disease Site:	Cancer control
Disease SubSite:	Breast
Drug Provided:	Acetyl L-Carnitine
Comments:
Eligibility:	Histologically confirmed primary invasive adenocarcinoma of the breast, Stage I-IIIA disease, No metastatic disease, Must have undergone modified radical mastectomy or breast-sparing surgery and radiotherapy, Planning to receive one of the following standard taxane-based systemic chemotherapy regimens as adjuvant therapy for breast cancer: Paclitaxel 80 mg/m² weekly for 12 weeks, Paclitaxel 175 mg/m² every other week for 4 courses (8 weeks), Paclitaxel 175 mg/m² every other week for 6 courses (12 weeks) , Docetaxel 75 mg/m² every 3 weeks for 4 courses (12 weeks), Docetaxel 75 mg/m² every 3 weeks for 6 courses (18 weeks), No history of neuropathy, Hormone receptor status not specified, Prior/Concurrent Therapy: See Disease Characteristics, Prior neoadjuvant chemotherapy allowed, No prior taxane therapy or biologic therapy, Concurrent biologic therapy allowed, No concurrent vitamin E, glutamine, gabapentin, nortriptyline, amitriptyline, or duloxetine hydrochloride, No concurrent anti-seizure medications, Concurrent hormonal therapy allowed, Concurrent participation in another therapeutic clinical trial allowed.

Title:	Phase II ERCC 1and RRM1-Based Adjuvant Therapy Trial in Patients with Stage I Non-Small Cell Lung Cancer (NSCLC) - IRB# 09-002A
Treatments:	Cisplatin, Gemcitabine
Disease Site:	Lung
Disease SubSite:	Non Small Cell Lung
Drug Provided:	-- none --
Comments:
Eligibility:	Histologically confirmed non-small cell lung cancer. Stage IA (longest tumor diameter 2-3 cm) or stage IB disease. Must have undergone preoperative CT scan of the chest (including the entire liver and adrenals) with IV contrast AND a whole body PET scan or a combined PET/CT scan with no evidence of N1, N2, N3, or M1 disease within 42 days prior to surgery. Completely resected (R0) disease by lobectomy, bilobectomy, or pneumonectomy performed by open thoracotomy or video-assisted thoracoscopic surgery within the past 35 days. Completely excised primary lesion with negative gross and microscopic margins. At least two mediastinal lymph node stations sampled. Must have tumor tissue available from the surgical resection specimen AND agree to have treatment assignment determined by a gene expression analysis performed on that tissue. Prior/Concurrent Therapy: See Disease Characteristics. No prior systemic chemotherapy or biologic therapy for lung cancer. No prior thoracic radiation therapy (RT) (including RT to the chest wall). No other concurrent investigational agents, chemotherapeutic agents, RT, or hormonal therapy. Steroids administered for antiemesis, adrenal failure, or septic shock OR hormones administered for non-disease-related conditions (e.g., insulin for diabetes) allowed.

Title:	A Phase II Trial of mTOR Inhibitor, Everolimus, (RAD001) in Malignant Pleural Mesothelioma (MPM) - IRB# 09-46B
Treatments:	Everolimus
Disease Site:	Lung
Disease SubSite:
Drug Provided:	Everolimus
Comments:
Eligibility:	Histologically confirmed malignant pleural mesothelioma, unresectable disease, must have measurable or nonmeasurable disease by RECIST or modified RECIST criteria. Must have received prior systemically administered* platinum-based chemotherapy and meets the following criteria: No more than 2 prior systemic therapeutic regimens allowed (including biologics, targeted, and immunotherapies). At least 1 regimen must have been platinum-based, neoadjuvant and/or adjuvant systemic therapy is not counted as a prior regimen, assuming =>12 weeks have elapsed between the end of neoadjuvant/adjuvant therapy and development of progressive disease.[Note: *Pleural space washing with cisplatin does not constitute systemic administration], No known CNS metastases, Prior/Concurrent Therapy: See Disease Characteristics. Recovered from all prior therapy. At least 28 days since prior systemic therapy (42 days for nitrosoureas or mitomycin C). At least 28 days since prior thoracic or other major surgery (e.g., pleurectomy or pleurodesis) and no anticipated need for major surgical procedures during study. At least 14 days since prior radiotherapy. No prior surgical procedure affecting absorption. No prior chronic, systemic corticosteroids or other immunosuppressive agent, except corticosteroids equivalent to prednisone =< 20 mg daily. Must have been on a stable dosage regimen for => 4 weeks. Topical and inhaled corticosteroids allowed. No prior mTOR inhibitor therapy (i.e., rapamycin, everolimus, or temsirolimus). No concurrent immunization with attenuated live vaccines. No concurrent antiretroviral therapy for HIV-positive patients. No other concurrent investigational therapy. No other concurrent anticancer agents.

Title:	A Randomized Phase III Trial of CC-5-13 (lenalidomide, NSD-703813) and Low Dose Dexamethasone (LLD) versus Bortezomib (PS-341, NSC-681239), Lenalidomide and Low Dose Dexamethasone (BLLD) for Induction, in Patients with Previously Untreated Multiple Myeloma without an Intent for Immediate Autologous Stem Cell Transplant - IRB# 08-112A
Treatments:	Bortezomib (Velcade™, PS-341), Dexamethasone, Lenalidomide
Disease Site:	Multiple myeloma
Disease SubSite:
Drug Provided:	Bortezomib (Velcade™, PS-341), Lenalidomide
Comments:
Eligibility:	Newly diagnosed multiple myeloma (MM). Stage I, II, or III disease by the New International Staging System. Measurable disease, Nonsecretory MM based upon standard M-component criteria (i.e., measurable serum/urine M-component) is not allowed unless the baseline serum free light chain level (Freelite™) is elevated. Must be offered participation in the Myeloma Specimen Repository for banking and future research. Institutions must submit a local cytogenetics report and FISH analysis prior to study entry. Prior/Concurrent Therapy: No prior chemotherapy for this disease. No prior radiotherapy to a large area of the pelvis (i.e., more than half of the pelvis). No prior bortezomib or lenalidomide. Prior steroid treatment allowed provided treatment was no more than 2 weeks in duration. Must be able to take concurrent aspirin 325 mg daily (or enoxaparin 40 mg subcutaneously daily if allergic to aspirin) as prophylactic coagulation.

Title:	A Randomized Phase II Trial of Weekly Topotecan with and without AVE0005 (Aflibercept; NSC-724770) in Patients with Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC) - IRB #09-079A
Treatments:	AVE0005, Topotecan
Disease Site:	Lung
Disease SubSite:	Small cell
Drug Provided:	AVE0005
Comments:
Eligibility:	Histologically or cytologically confirmed diagnosis of extensive stage small cell lung cancer (E-SCLC) with progression or recurrence after receiving exactly one standard first-line platinum-containing regimen. Measurable or non-measurable disease. Brain mets eligible only if has been treated and stable for at least 3 months. No leptomeningeal involvement or brain stem mets. At least 21 days since prior RT. At least 28 days since surgery. No prior bevacizumab or other anti-angiogenic tx. Zubrod PS 0-1. At least 18 years of age. No active infection or bleeding. No uncontrolled hypertension. No history of recent arterial embolic events or congestive heart failure. No significant history of bleeding diathesis including hemoptysis or underlying coagulopathy. No prior history of encephalitis or encephalopathy.

Title:	A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC) - IRB# 09-47A
Treatments:	Capecitabine, Gemcitabine, Radiation Therapy
Disease Site:	Gastrointestinal
Disease SubSite:	Gallbladder
Drug Provided:	-- none --
Comments:
Eligibility:	Histopathologically confirmed extrahepatic cholangiocarcinoma of the gallbladder or bile duct, meeting at least 1 of the following criteria: Pathological T2-4 disease, Pathological N1 disease, Positive margins (any T or N ). Must have undergone potentially curative radical resection with negative (R0) or microscopically positive (R1) margins within the past 56 days and recovered. No distant metastatic disease as indicated by a CT scan or MRI of the chest, abdomen, and pelvis within the past 42 days. Positive resected regional lymph nodes allowed, No ampullary cancer. Prior/Concurrent Therapy: see Disease Characteristics. No prior chemotherapy or radiotherapy for this disease, No prior upper abdominal radiotherapy.

Title:	A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma using Interim FDG-PET Imaging - IRB# 09-089A
Treatments:	Bleomycin, Cyclophosphamide, Dacarbazine, Doxorubicin, Etoposide, Prednisone, Procarbazine, Vinblastine, Vincristine
Disease Site:	Lymphoma
Disease SubSite:	Hodgkins
Drug Provided:	-- none --
Comments:	PET after 2nd cycle provided.
Eligibility:	Histologically confirmed classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted). Previously untreated stage III or IV disease. No nodular lymphocyte predominant disease. Bidimensionally measurable disease. Adequate biopsy samples from original diagnostic specimen must be available for pathologic review. Tissue obtained from core biopsies allowed No tissue obtained from needle aspirations or cytologies. Must have known HIV status. No multi-drug resistant HIV infection, CD4 counts < 350/mcL, or other concurrent AIDS-defining conditions in HIV-positive patients. HIV-positive patients with CD4 counts => 350/mcL allowed. Must have undergone unilateral or bilateral bone marrow biopsy within the past 42 days. Prior/ Concurrent Therapy: See Disease Characteristics No prior chemotherapy, radiotherapy, or antibody therapy for lymphoma. No prior solid organ transplantation.

Title:	A Phase II Trial of SCH 727965 (NSC 747135) in Patients with Stage IV Melanoma - IRB #09-080A
Treatments:	SCH 727965
Disease Site:	Melanoma
Disease SubSite:
Drug Provided:	SCH 727965
Comments:
Eligibility:	Biopsy-confirmed malignant melanoma. Stage IV disease. Cutaneous or mucosal origin. Melanoma of unknown primary allowed. No ocular melanoma. Measurable or non-measurable disease . No prior or concurrent brain metastases as confirmed by CT scan or MRI. Prior/Concurrent Therapy: No prior therapy with a cyclin-dependent kinase inhibitor. At least 14 days since prior radiotherapy. At least 28 days since prior systemic chemotherapy. At least 28 days since prior adjuvant systemic therapy. At least 28 days since prior surgery. No more than 1 prior systemic therapy regimen (chemotherapy, biologic/immunotherapy, hormonal therapy, or a combination regimen) for stage IV melanoma and any side effects must have resolved to =< grade 1. Any number of prior adjuvant systemic therapy regimens allowed, including interferon alfa-2b, GM-CSF, chemotherapy, and chemobiotherapy. Therapy for stage IV resected free-of-disease will be considered adjuvant therapy.

Title:	Long Term Follow-Up Protocol: An Administrative Tool - IRB# 98-116B
Treatments:	Sentinel Node Resection
Disease Site:
Disease SubSite:	Ancillary
Drug Provided:	-- none --
Comments:
Eligibility:	Applicable S9808 protocols

Title:	Leukemia Centralized Reference Laboratories and Tissue Repositories, Ancillary - IRB# 99-081A
Treatments:	13-cis retinoic acid, Tissue repository
Disease Site:	Leukemia
Disease SubSite:	Tissue repository
Drug Provided:	-- none --
Comments:	SWOG (Reimbursement for the submission of specimens to this banking protocol will be made based on the requirements of each associated treatment protocol).
Eligibility:	Patients must be registered on a Southwest Oncology Group leukemia treatment study on or after the date of activation of this study.

Title:	"ExCap - A Study of the Effects of Excercise on Cancer-Related Fatigue" NCI# URCC 0701 - URCC # UCCO08106 - IRB #09-100A
Treatments:	Exercise
Disease Site:	Cancer control
Disease SubSite:
Drug Provided:	-- none --
Comments:	All study costs provided
Eligibility:	Study participants must: Have a primary diagnosis of cancer, with no distant metastasis. Be starting chemotherapy treatments for cancer and be scheduled for at least 6 weeks of treatments with treatment cycles of either 2 or 3 weeks. Have a functional capacity rating of 70 or greater on the Karnofsky Performance. Scale (SECSG) when assessed by the medical oncologist (or physician’s designee) at the beginning of chemotherapy treatments. (Clinical Record Information form question #3). Be able to read English (since the assessment materials are in printed format). Be 21 years of age or older. Exclusion criteria: Study participants must not: Have metastatic disease. Have had chemotherapy within the past six months, be receiving concurrent radiation therapy. Have physical limitations (e.g., cardiorespiratory, orthopedic, central nervous system) that contraindicate participation in a low to moderate intensity home-based walking, and progressive resistance program, as assessed by the medical oncologist (or physician’s designee). Be identified as in the active or maintenance stage of exercise behavior as assessed by the 1-item Exercise Stages of Change Short Form (which will be assessed).

Title:	"Assessment of Topical Treatment Response with Amitriptyline and Ketamine: Combination Trial in Chemotherapy Peripheral Neuropathy" NCI # URCC 06-05 aka URCC # URCC07004 - IRB# 07-137B
Treatments:	EpiCept-NP-1 cream
Disease Site:	Cancer control
Disease SubSite:	Neuropathy
Drug Provided:	EpiCept-NP-1 cream
Comments:
Eligibility:	Must be male or female 18 years of age or older. Pain in lower extremities beginning in association with cancer chemotherapy and persisting for at least 29 days following the conclusion of the chemotherapy, an average score of equal to or less than 4 for the 7 daily ratings of the baseline week on the 11-point rating scale of lower-extremity pain associated with chemotherapy, with a minimum of 5 daily diary rating completed during the baseline week. See protocol for specifics.