Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium
NCT00397488
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- New York, New York
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium | |||
Official Title ICMJE | Phase II Study of Sunitinib in Metastatic Transitional Cell Carcinoma of the Urothelium | |||
Brief Summary | RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for their growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with progressive metastatic transitional cell cancer of the urothelium. | |||
Detailed Description | OBJECTIVES: Primary
Secondary
| |||
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 |
| |||
Intervention ICMJE | Drug: sunitinib malate | |||
Study Arms ICMJE | Experimental: Sunitinib
This is a phase II trial of Sunitinib in patients with metastatic urothelial carcinoma. Sunitinib will be administered at a dose of 50 mg orally once daily for four consecutive weeks followed by a two-week rest period for the initial population. A second cohort of patients will be enrolled, who will receive 37.5 mg of sunitinib orally, on a continuous dosing schedule. Intra-patient dose reduction may be required depending on the type and severity of individual toxicity encountered. Re-staging imaging studies will be performed after every cycle of treatment during the first 4 cycles and subsequently after every other cycle. Patients may continue on study as long as they are tolerating therapy and in the absence of disease progression. Intervention: Drug: sunitinib malate | |||
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 | Completed | |||
Actual Enrollment ICMJE | 78 | |||
Original Enrollment ICMJE | 41 | |||
Actual Study Completion Date ICMJE | February 2012 | |||
Actual Primary Completion Date | February 2012 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 120 Years (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 | NCT00397488 | |||
Other Study ID Numbers ICMJE | 06-081 MSKCC-06081 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Memorial Sloan Kettering Cancer Center | |||
Study Sponsor ICMJE | Memorial Sloan Kettering Cancer Center | |||
Collaborators ICMJE |
| |||
Investigators ICMJE |
| |||
PRS Account | Memorial Sloan Kettering Cancer Center | |||
Verification Date | December 2015 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |