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.
OBJECTIVES: Primary * 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. Secondary * To evaluate the link between the time to progression and the development of VEGF and IL-6 CXCL7 and CXCK5 blood levels in these patients. * To evaluate the link between VEGF and IL-6 CXCL7 and CXCK5 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-6 CXCL7 and CXCK5 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Centre Antoine Lacassagne
Nice, France
Disease response
Time frame: 5 years
VEGF and IL-8 blood levels determined before and every 6 weeks during treatment
Time frame: 5 years
Length of the response
Time frame: up to 5 years
Disease-free survival
Time frame: up to 5 years
Overall survival
Time frame: up to 5 years
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