C90601 A Randomized double-blinded Phase III study comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin,and Placebo in patients with advanced Transitional Cell Carcinoma
To determine if patients with advanced Transitional Cell Carcinoma treated with bevacizumab, gemcitabine and cisplatin will have increased overall survival when compared to patients treated with gemcitabine, cisplatin, and placebo.To compare the progression-free survival and grade 3 and greater toxicities in patients treated on these two regimens.
Pathologically confirmed metastatic or unresectable Transitional Cell Carcinoma of the urinary tract with progressive metastatic disease or locally advanced disease . No prior combination chemotherapy for metastatic disease Prior neoadjuvant or adjuvant therapy is permissible, provided the interval from end of therapy to diagnosis of metastatic disease is at least 1 year. - ï¿½ 4 weeks since any radiation therapy (including palliative) or major surgery and fully recovered - ï¿½ 4 weeks from any intravesical therapy - No prior treatment with bevacizumab or other angiogenesis inhibitors. No known brain metastases (brain imaging (MRI/CT) is not required). No current congestive heart failure (NYHA Class 2 or higher). Patients with history of hypertension must be well controlled ( less than 150/90). Patients on full-dose anticoagulants must be on a stable dose of warfarin and have an in-range INR or be on a stable dose of LMW heparin No significant history of bleeding events within 6 months of registration (except for hematuria able to be controlled with endoscopic intervention) No history of gastrointestinal perforation within 12 months of registration No clinically significant peripheral arterial disease No arterial thrombotic events within 6 months No serious or non-healing wound, ulcer or bone fracture. No clinically significant peripheral neuropathy (grade ï¿½ 2). Patients that are pregnant or nursing are not eligible No known hypersensitivity to Chinese hamster ovary cell products ECOG Performance Status: 0-1. Age ï¿½ 18.
ARM A. (6 cycles) each cycle is 21 days Gemcitabine on Day 1 and Day 8 of every cycle Cisplatin on Day 1 Placebo on Day 1 every 21 days ARM B (until disease progression or unacceptable) Gemcitabine on Day 1 and Day 8 of every cycle Cisplatin on Day 1 Bevacizumab on Day 1 every 21 days
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