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Title:
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A Randomized Phase III Study of Gemcitabine, Cisplatin, Bevacizumab or Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma - IRB# 09-090B
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Treatments:
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Bevacizumab, Cisplatin, Gemcitabine
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Disease Site:
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Genitourinary
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Disease SubSite:
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Bladder
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Drug Provided:
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Bevacizumab
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Comments:
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Eligibility:
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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.
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Participating Sites:
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Adventist Medical Center, Northwest Cancer Specialists, Providence Milwaukie Hospital, Providence Portland Medical Center, Providence St. Vincent Medical Center, Southwest Washington Medical Center
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