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

Phase 2

Completed

• Conditions: Kidney Cancer

• Registration Number: NCT00541008
• Lead Sponsor: UNICANCER

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.

Study Timeline

• Study Start: 2007-09-05
• Study First Submitted: 2007-10-05
• Study First Submitted QC: 2007-10-05
• Study First Posted: 2007-10-08
• Primary Completion: 2011-02
• Study Completion: 2013-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Objective tumor response rate

Secondary Outcome Measures

Name	Time	Method
Safety
Duration of response
Time to disease progression
Overall survival
Time to response

Trial Locations

Locations (22)

Hopital Saint Michel; 🇫🇷 Paris, France

CHU de la Timone; 🇫🇷 Marseille, France

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

Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes; 🇫🇷 Marseille, France

Centre Leon Berard; 🇫🇷 Lyon, 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

Institut Jean Godinot; 🇫🇷 Reims, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Hopital Foch; 🇫🇷 Suresnes, France

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre Hospitalier Universitaire Bretonneau de Tours; 🇫🇷 Tours, France