Conditions: Bladder Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 54
Healthy volunteers: no

Brief summary:
This study is a randomized, blinded, placebo-controlled study evaluating the drug, SUO11248 (SUTENT), for maintenance therapy in advanced urothelial cancer.

Detailed description:

Arms:
arm 1: Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks. arm 2: Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.

Interventions: intervention 1: SUTENT intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg/PO once daily for four consecutive weeks with a two week rest period. Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded. Participants receiving SU011248 will be removed from the study. Participants receiving placebo will be given the opportunity to "crossover" and receive SU011248. intervention 2: None

Protocol document: