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

This study has been terminated.
(STudy closed due to poor accrual)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Cheryl Lee, University of Michigan
ClinicalTrials.gov Identifier:
NCT01042795
First received: January 5, 2010
Last updated: January 17, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Urothelial Carcinoma
Bladder Cancer
Drug: Sunitinib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • Disease Free Survival [ Time Frame: 2- year ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: September 2009
Study Completion Date: January 2013
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Continuous Daily Dosing of Sunitinib Drug: Sunitinib
Sunitinib 37.5 mg daily X 16 weeks
Other Name: Sutent

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01042795

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
Sponsors and Collaborators
University of Michigan
Pfizer
  More Information

No publications provided

Responsible Party: Cheryl Lee, Associate Professor of Urology, University of Michigan
ClinicalTrials.gov Identifier: NCT01042795     History of Changes
Other Study ID Numbers: HUM00030127
Study First Received: January 5, 2010
Last Updated: January 17, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
sunitinib
bladder neoplasm
adjuvant treatment
disease free survival
Patients with extravesical tumor (pT2-4,Nany, M0 or pTanyN+M0) after cystectomy and platin-based neoadjuvant chemotherapy

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014