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

Primary Purpose

Urothelial Carcinoma, Bladder Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Sunitinib

About this trial

This is an interventional treatment trial for Urothelial Carcinoma focused on measuring sunitinib, bladder neoplasm, adjuvant treatment, disease free survival, cystectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

University of Michigan

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Continuous Daily Dosing of Sunitinib

Arm Description

Outcomes

Primary Outcome Measures

Disease Free Survival

2-year disease free survival

Secondary Outcome Measures

Full Information

NCT ID

NCT01042795

First Posted

January 5, 2010

Last Updated

May 26, 2017

Sponsor

University of Michigan

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01042795

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Terminated

Why Stopped

Study closed due to poor accrual

Study Start Date

September 2009 (undefined)

Primary Completion Date

April 2012 (Actual)

Study Completion Date

January 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urothelial Carcinoma, Bladder Cancer

Keywords

sunitinib, bladder neoplasm, adjuvant treatment, disease free survival, cystectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Continuous Daily Dosing of Sunitinib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Sunitinib

Other Intervention Name(s)

Sutent

Intervention Description

Sunitinib 37.5 mg daily X 16 weeks

Primary Outcome Measure Information:

Title

Disease Free Survival

Description

2-year disease free survival

Time Frame

2- year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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