Clinical Trial: Sunitinib in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study of Sunitinib in Patients With Metastatic Papillary Renal Cell Carcinoma
Brief Summary:
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.
Detailed Summary:
OBJECTIVES:
Primary
- 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.
Sponsor: Memorial Sloan Kettering Cancer Center
Current Primary Outcome: Overall Objective Response Rate as Measured by RECIST [ Time Frame: 2 years ]
Original Primary Outcome: Efficacy as measured by rate of complete response plus partial response
Current Secondary Outcome:
Original Secondary Outcome:
- Toxicity
- Number of courses to maximal response
- Duration of response
Information By: Memorial Sloan Kettering Cancer Center
Dates:
Date Received: April 11, 2007
Date Started: March 2007
Date Completion:
Last Updated: October 26, 2015
Last Verified: October 2015
