A Randomized Double-blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma

Summary:
This study aims to determine if patients with advanced transitional cell carcinoma (TCC) treated with bevacizumab, gemcitabine and cisplatin will have increased overall survival when compared to patients treated with gemcitabine, cisplatin, and placebo.

Bevacizumab has shown significant clinical activity in other cancer types. It has been successfully combined with gemcitabine and cisplatin in other diseases. Based on the evidence from other research studies that have found TCC is a chemo-sensitive disease, and that bevacizumab improves chemotherapy delivery, locally advanced or metastatic Transitional cell carcinoma represents an opportunity to further explore this treatment regimen.

Eligibility and Treatment Plan:
• Male or female of at least 18 years old
• Metastatic or unresectable transitional cell carcinoma of the urinary tract with progressive metastatic disease or locally advanced disease
• No known brain metastases;
• No prior combination chemotherapy for metastatic disease;
• No prior treatment with bevacizumab or other angiogenesis inhibitors

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