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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:
ClinicalTrials.gov Identifier:
NCT01042795
First Posted: January 6, 2010
Last Update Posted: June 28, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Cheryl Lee, University of Michigan
  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: Intervention Model: Single Group Assignment
Masking: None (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 Cheryl Lee, University of Michigan:

Primary Outcome Measures:
  • Disease Free Survival [ Time Frame: 2- year ]
    2-year disease free survival


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042795


Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
Pfizer
  More Information

Responsible Party: Cheryl Lee, Associate Professor of Urology, University of Michigan
ClinicalTrials.gov Identifier: NCT01042795     History of Changes
Other Study ID Numbers: HUM00030127
First Submitted: January 5, 2010
First Posted: January 6, 2010
Results First Submitted: April 11, 2017
Results First Posted: June 28, 2017
Last Update Posted: June 28, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Cheryl Lee, University of Michigan:
sunitinib
bladder neoplasm
adjuvant treatment
disease free survival
cystectomy

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