CTSU CALGB 90601: A Randomized Double-Blinded Phase III Study Comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in Patients with Advanced Transitional Cell Carcinoma
February 06, 2010
Cancer - Genitourinary/ Bladder/ Prostate/ Urothel
Principal Investigator: Robert A Chapman, MD
The purpose of this clinical trial is 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.
Patients must have histologically documented metastatic or unresectable transitional cell carcinoma of the urinary tract (renal pelvis, ureter, bladder, prostate, or urethra), with progressive metatstatic or locally advanced disease (T4b, N2, N3, or M1); Patients must not be candidates for potentially curative surgery or radiotherapy; Patients may not have received combination systemic chemotherapy for metastatic disease.