|
|
 |
|
 |
|
|
|
|
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.
|
|
Participating Sites:
|
Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
|
|
|
|
|
 |
|
 |
|
|
|