Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Sunitinib in Patients With Metastatic Papillary Renal Cell Carcinoma|
- Efficacy as measured by rate of complete response plus partial response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Toxicity [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Number of courses to maximal response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
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|
- Determine the efficacy of sunitinib malate in patients with locally recurrent or metastatic papillary renal cell carcinoma.
- Determine the safety of this drug in these patients.
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|