Urinary tract cancer study

Full Name

Urinary Tract Cancer (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, NCI supplies agent(s) bevacizumab/placebo (NSC 704865m UBC #7921) (1_PRO00000604 - CIRB)

Description

This study is for patients with advanced transitional cell carcinoma. Participants will be randomized by chance to Arm A or Arm B. Arm A participants will be give Gemcitabine, Cisplatin and placebo for 6 cycles followed by placebo every 21 days; Arm B participants will be given Gemcitabine, Cisplatin and Bevacizumab for 6 cycles followed by Bevacizumab every 21 days. A cycle consists of 21 days. Participants receiving Bevacizumab or placebo alone will continue until disease progression or unacceptable side effects.

Eligibility

Inclusion Criteria

o Have diagnosis of Mets or Unresectable transitional cell CA
o Cannot be a candidate for potentially curative surgery or radiotherapy
o No known brain mets
o Appropriate previous treatments
o Age 18 or older
o Appropriate blood work
o Cannot be pregnant or become pregnant