Clinical Trial: Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer
Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase II of Sunitinib (SUTENT®) in First Line for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma - SUPAP
Brief Summary:
RATIONALE: Sunitinib may stop the growth of cancer 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 as first-line therapy in treating patients with locally advanced or metastatic papillary renal cell (kidney) cancer.
Detailed Summary:
OBJECTIVES:
Primary
- To determine the objective tumor response rate in patients with locally advanced or metastatic papillary renal cell carcinoma treated with sunitinib malate.
Secondary
- To evaluate the safety of this drug in these patients.
- To determine time-to-event variables of overall survival, time to disease progression, time to response, and duration of response in patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once a day 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 then periodically thereafter.
Sponsor: UNICANCER
Current Primary Outcome: Objective tumor response rate
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety
- Overall survival
- Time to disease progression
- Time to response
- Duration of response
Original Secondary Outcome: Same as current
Information By: National Cancer Institute (NCI)
Dates:
Date Received: October 5, 2007
Date Started: September 2007
Date Completion:
Last Updated: August 13, 2011
Last Verified: August 2011