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.
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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Centre Paul Papin
Angers, France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, France
Objective tumor response rate
Safety
Overall survival
Time to disease progression
Time to response
Duration of response
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