Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00459875|
Recruitment Status : Completed
First Posted : April 13, 2007
Results First Posted : November 26, 2015
Last Update Posted : November 26, 2015
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with locally recurrent or metastatic kidney cancer.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: sunitinib malate||Phase 2|
- Determine the efficacy of sunitinib malate in patients with locally recurrent or metastatic papillary renal cell carcinoma.
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 at 28 days and every 2 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Sunitinib in Patients With Metastatic Papillary Renal Cell Carcinoma|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.
Drug: sunitinib malate
- Overall Objective Response Rate as Measured by RECIST [ Time Frame: 2 years ]
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): NCT00459875
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Glenn Kroog, MD||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Robert J. Motzer, MD||Memorial Sloan Kettering Cancer Center|