Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
The purpose of this study is to determine whether sutent (sunitinib)is effective in preventing tumor recurrence in patients with high risk bladder cancer who have previously had chemotherapy and cystectomy (bladder removal).
A 4 month supply of the drug is given to patients beginning 2-3 months after bladder removal. The patients are followed up to 2 years.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy|
- Disease Free Survival [ Time Frame: 2- year ] [ Designated as safety issue: No ]
|Study Start Date:||September 2009|
|Study Completion Date:||January 2013|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
|Experimental: Continuous Daily Dosing of Sunitinib||
Sunitinib 37.5 mg daily X 16 weeks
Other Name: Sutent