Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
|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 ]
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|