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Brief Title: Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer
Official Title: Phase II of Sunitinib (SUTENT®) in First Line for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma - SUPAP
Study ID: NCT00541008
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 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Centre Paul Papin, Angers, , France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz, Besancon, , France
Hopital Saint Andre, Bordeaux, , France
C.H.U. de Brest, Brest, , France
Centre Regional Francois Baclesse, Caen, , France
CHU de Grenoble - Hopital de la Tronche, Grenoble, , France
Centre Hospitalier Departemental, La Roche Sur Yon, , France
Centre Oscar Lambret, Lille, , France
Centre Leon Berard, Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes, Marseille, , France
CHU de la Timone, Marseille, , France
Hopital Notre-Dame de Bon Secours, Metz, , France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier, , France
CRLCC Nantes - Atlantique, Nantes-Saint Herblain, , France
Centre Antoine Lacassagne, Nice, , France
Hopital Europeen Georges Pompidou, Paris, , France
Hopital Saint Michel, Paris, , France
Institut Jean Godinot, Reims, , France
Hopital Foch, Suresnes, , France
Institut Claudius Regaud, Toulouse, , France
Centre Hospitalier Universitaire Bretonneau de Tours, Tours, , France
Institut Gustave Roussy, Villejuif, , France
Name: Alain Ravaud, MD, PhD
Affiliation: Hopital Saint Andre
Role: