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

Bladder Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01042795
• Other study ID #: HUM00030127
• Status: Terminated
• Phase: Phase 2
• First received: January 5, 2010
• Last updated: January 17, 2013
• Start date: September 2009
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Drug:
• Sunitinib
Sunitinib 37.5 mg daily X 16 weeks

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease Free Survival		2- year	No