Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy

Stopped early · Phase 2

Conditions studied: Urothelial Carcinoma, Bladder Cancer

In brief

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.

Key facts

Study ID

NCT01042795

Run by

University of Michigan

People needed

7

Starts

2009-09-01

Expected to finish

2013-01-01

Last updated by the study team

2017-06-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Severe or uncontrolled acute or chronic medical or psychiatric condition
• Prior antiangiogenic therapy
• Prior pelvic radiation for bladder cancer

Where it is running

• University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.