Primary Outcome Measures:
blinded-SU011248 or Placebo given at 50 mg/day as single agent for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks. Suty drug will be orally self administered once daily without regard to meals beginning on Day 1 of the study.
The primary objective of this study is to compare the progression rate associated with SU011248 versus Placebo in patients with advanced urothelial carcinoma who have achieved at least stable disease following combination chemotherapy. Secondary objectives of the trial: We will explore the safety of SU011248, assess the objective response rate associated with SU011248 therapy in patients with stable disease after chemotherapy, and assess the median survival in patients with advanced urothelial carcinoma treated with SU011248 or placebo following chemotherapy. Correlative objectives of trial: To correlate changes in VEGF and sVEGFR-2 levels with clinical response in patients with advanced urothelial carcinoma. Tertiary objective of trial: Determine response and progression rates to SU011248 in patients crossed over to treatment after placebo.