Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium
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|ClinicalTrials.gov Identifier: NCT00397488|
Recruitment Status : Completed
First Posted : November 9, 2006
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
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 or disease||Intervention/treatment||Phase|
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: sunitinib malate||Phase 2|
- Determine the response rate in patients with progressive metastatic transitional cell carcinoma of the urothelium treated with sunitinib malate.
- Determine the safety of this regimen in these patients.
Determine the time to disease progression in patients treated with this regimen.
- To determine time to tumor progression (TTP) for sunitinib malate on a continuous dosing schedule for treatment of metastatic urothelial carcinoma.
- To estimate sunitinib and SU012662 trough plasma concentration (Ctrough) data for the continuous daily schedule and to determine potential association with efficacy and safety.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Sunitinib in Metastatic Transitional Cell Carcinoma of the Urothelium|
|Study Start Date :||September 2006|
|Actual Primary Completion Date :||February 2012|
|Actual Study Completion Date :||February 2012|
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.
Drug: sunitinib malate
- Overall Objective Response [ Time Frame: 2 years ]Response rate as measured by RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria
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): NCT00397488
|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|