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

University of Michigan

Status and phase: Terminated; Phase 2

Conditions: Bladder Cancer; Urothelial Carcinoma

Treatments: Drug: Sunitinib

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01042795

HUM00030127

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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7 participants in 1 patient group

Continuous Daily Dosing of Sunitinib

Experimental group

Treatment:

Drug: Sunitinib