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Spots Global Cancer Trial Database for Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer

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Trial Identification

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

Conditions

Kidney Cancer

Interventions

sunitinib malate

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Alain Ravaud, MD, PhD

Affiliation: Hopital Saint Andre

Role:

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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