Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
| Status: | Recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Cancer, Bladder Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 11/18/2012 |
| Start Date: | September 2009 |
Phase II 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.
Inclusion Criteria:
- Histologic diagnosis of bladder carcinoma (>50% urothelial carcinoma)
- Prior treatment with at least one cycle of platin-based neoadjuvant chemotherapy
- Prior treatment with radical cystectomy revealing pT3NxM0 or pTanyN+M0
- ECOG performance status of 0-1 (Appendix 2).
- No evidence of metastases within 4 weeks of registration
- Adequate organ and marrow function obtained within 14 days of registration
Exclusion Criteria:
- Severe or uncontrolled acute or chronic medical or psychiatric condition
- Prior antiangiogenic therapy
- Prior pelvic radiation for bladder cancer
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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