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

Information source: University of Michigan
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urothelial Carcinoma; Bladder Cancer

Intervention: Sunitinib (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: University of Michigan

Summary

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.

Clinical Details

Official title: Phase II Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Disease Free Survival

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

University of Michigan, Ann Arbor, Michigan, United States
Additional Information

Starting date: September 2009
Last updated: January 17, 2013

Page last updated: August 23, 2015

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