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

NCT01042795

Last updated date
Study Location
University of Michigan
Ann Arbor, Michigan, 48109, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urothelial Carcinoma, Bladder Cancer
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Severe or uncontrolled acute or chronic medical or psychiatric condition


- Prior antiangiogenic therapy


- Prior pelvic radiation for bladder cancer

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Urothelial Carcinoma, Bladder CancerTrial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
NCT01042795
  1. Ann Arbor, Michigan
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
Official Title  ICMJE Phase II Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Urothelial Carcinoma
  • Bladder Cancer
Intervention  ICMJE Drug: Sunitinib
Sunitinib 37.5 mg daily X 16 weeks
Other Name: Sutent
Study Arms  ICMJE Experimental: Continuous Daily Dosing of Sunitinib
Intervention: Drug: Sunitinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 17, 2013)
7
Original Estimated Enrollment  ICMJE
 (submitted: January 5, 2010)
33
Actual Study Completion Date  ICMJE January 2013
Actual Primary Completion Date April 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01042795
Other Study ID Numbers  ICMJE HUM00030127
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party Cheryl Lee, University of Michigan
Study Sponsor  ICMJE University of Michigan
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account University of Michigan
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP