Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the Brain
RATIONALE: Sunitinib may stop the growth of tumor 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 in treating patients with kidney cancer that has spread to the brain.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study, Multicenter, Open-label, Evaluating Efficacy of Treatment With Sutent® (Sunitinib) in Patients With Previously Untreated or Recurrent Brain Metastases Originating From Renal Cancer|
- Objective response rate in the brain after 2 courses [ Time Frame: From beginning of treatment until 2 courses of treatment ]
|Study Start Date:||April 2009|
|Study Completion Date:||March 2011|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
- Determine the objective response rate in the brain after 2 courses of sunitnib malate in patients with previously untreated or recurrent brain metastases secondary to renal cancer following radiotherapy or surgery.
- Evaluate duration of response.
- Evaluate objective response of non-CNS targets.
- Evaluate time to disease progression.
- Evaluate overall and progression-free survival.
- Evaluate neurological symptoms associated with the tumor.
- Evaluate feasibility and overall tolerance of this drug.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily for 4 weeks. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 6 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00814021
|Institut Claudius Regaud|
|Toulouse, France, 31052|
|Study Chair:||Christine Chevreau-Dalbianco, MD||Institut Claudius Regaud|