Sunitinib as First-Line Therapy in Treating Patients With Locally Advanced Metastatic Papillary Renal Cell Cancer
Recruitment status was: Recruiting
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II of Sunitinib (SUTENT®) in First Line for Patients With Locally Advanced or Metastatic Papillary Renal Cell Carcinoma - SUPAP|
- Objective tumor response rate
- Overall survival
- Time to disease progression
- Time to response
- Duration of response
|Study Start Date:||September 2007|
- To determine the objective tumor response rate in patients with locally advanced or metastatic papillary renal cell carcinoma treated with sunitinib malate.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541008
|Centre Paul Papin|
|Angers, France, 49036|
|Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz|
|Besancon, France, 25030|
|Hopital Saint Andre|
|Bordeaux, France, 33075|
|C.H.U. de Brest|
|Brest, France, 29609|
|Centre Regional Francois Baclesse|
|Caen, France, 14076|
|CHU de Grenoble - Hopital de la Tronche|
|Grenoble, France, 38043|
|Centre Hospitalier Departemental|
|La Roche Sur Yon, France, 85025|
|Centre Oscar Lambret|
|Lille, France, 59020|
|Centre Leon Berard|
|Lyon, France, 69373|
|Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes|
|Marseille, France, 13273|
|CHU de la Timone|
|Marseille, France, 13385|
|Hopital Notre-Dame de Bon Secours|
|Metz, France, 57038|
|Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle|
|Montpellier, France, 34298|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Hopital Saint Michel|
|Paris, France, 75015|
|Institut Jean Godinot|
|Reims, France, 51056|
|Suresnes, France, 92151|
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Centre Hospitalier Universitaire Bretonneau de Tours|
|Tours, France, 37044|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|OverallOfficial:||Alain Ravaud, MD, PhD||Hopital Saint Andre|