NCT00541008

Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer

Phase II of Sunitinib (SUTENT®) in First Line for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma - SUPAP

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: UNICANCER · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

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 description

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	sunitinib malate

Timeline

• Start date: 2007-09-05
• Primary completion: 2011-02-01
• Completion: 2013-04-01
• First posted: 2007-10-08
• Last updated: 2021-02-21

Locations

22 sites across 1 country: France