Sunitinib Malate in Treating Patients With Kidney Cancer
RATIONALE: Sunitinib malate 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 clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer.
Drug: sunitinib malate
Other: laboratory biomarker analysis
Other: pharmacological study
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of Sunitinib in the Expression of VEGF and of Interleukin 8: Explanation of Anti-angiogenic Effects.|
- Disease response [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
- VEGF and IL-8 blood levels determined before and every 6 weeks during treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- Length of the response [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
- Disease-free survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Study Completion Date:||December 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
|Experimental: SUVEGIL||Drug: sunitinib malate Other: laboratory biomarker analysis Other: pharmacological study|
- To determine whether a link exists between the effectiveness of therapy with sunitinib malate and development of blood biomarkers, specifically the angiogenic factors VEGF and interleukin-8 (IL-8), in patients with kidney cancer.
- To evaluate the link between the time to progression and the development of VEGF and IL-8 blood levels in these patients.
- To evaluate the link between VEGF and IL-8 blood levels and disease-free survival of these patients after 3, 6, 9, and 12 months of treatment.
- To evaluate the link between VEGF and IL-8 blood levels and overall survival of these patients.
OUTLINE: This is a multicenter study.
Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and then every 6 weeks for pharmacokinetic analysis.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00943839
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Principal Investigator:||Jean Marc Ferrero, MD||Centre Antoine Lacassagne|