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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01042795
Other study ID # HUM00030127
Secondary ID
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


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
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