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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00397488 |
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.
Condition | Intervention | Phase |
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Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer |
Drug: sunitinib malate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of Sunitinib in Metastatic Transitional Cell Carcinoma of the Urothelium |
Estimated Enrollment: | 41 |
Study Start Date: | September 2006 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 41 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed transitional cell carcinoma of the urothelium, including 1 of the following sites:
Progressive metastatic disease
Previously treated disease, as defined by the following:
Prior therapy must have included ≥ 1 of the following:
PATIENT CHARACTERISTICS:
None of the following within the past 6 months:
PRIOR CONCURRENT THERAPY:
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Principal Investigator: | Dean F. Bajorin, MD | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Dean F. Bajorin ) |
Study ID Numbers: | CDR0000510910, MSKCC-06081 |
Study First Received: | November 8, 2006 |
Last Updated: | April 3, 2009 |
ClinicalTrials.gov Identifier: | NCT00397488 History of Changes |
Health Authority: | United States: Federal Government |
recurrent bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder anterior urethral cancer posterior urethral cancer |
recurrent urethral cancer metastatic transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter urethral cancer associated with invasive bladder cancer |
Urinary Tract Neoplasm Kidney Cancer Cystocele Urinary Bladder Diseases Urinary Bladder Neoplasms Ureteral Diseases Urogenital Neoplasms Carcinoma, Transitional Cell Urologic Neoplasms Angiogenesis Inhibitors Recurrence Carcinoma |
Renal Cancer Urologic Diseases Sunitinib Kidney Neoplasms Urethral Cancer Urethral Neoplasms Bladder Neoplasm Kidney Diseases Ureteral Neoplasms Transitional Cell Carcinoma Neoplasms, Glandular and Epithelial |
Antineoplastic Agents Physiological Effects of Drugs Ureteral Diseases Urogenital Neoplasms Urologic Neoplasms Carcinoma, Transitional Cell Neoplasms by Site Urologic Diseases Kidney Neoplasms Sunitinib Therapeutic Uses Urethral Diseases Growth Inhibitors |
Kidney Diseases Angiogenesis Modulating Agents Neoplasms by Histologic Type Growth Substances Urinary Bladder Diseases Urinary Bladder Neoplasms Angiogenesis Inhibitors Pharmacologic Actions Carcinoma Neoplasms Urethral Neoplasms Ureteral Neoplasms Neoplasms, Glandular and Epithelial |