Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
NCT ID: NCT01042795
Last Updated: 2017-06-28
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
7 participants
INTERVENTIONAL
2009-09-30
2013-01-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Continuous Daily Dosing of Sunitinib
Sunitinib
Sunitinib 37.5 mg daily X 16 weeks
Interventions
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Sunitinib
Sunitinib 37.5 mg daily X 16 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Prior antiangiogenic therapy
* Prior pelvic radiation for bladder cancer
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
University of Michigan
OTHER
Responsible Party
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Cheryl Lee
Associate Professor of Urology
Locations
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University of Michigan
Ann Arbor, Michigan, United States
Countries
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Other Identifiers
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HUM00030127
Identifier Type: -
Identifier Source: org_study_id
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