Sunitinib Malate in Treating Patients With Kidney Cancer

Effects of Sunitinib in the Expression of VEGF and of Interleukin 6 and CXCL7 - CXCL5 Cytokins : Explanation of Anti-angiogenic Effects.

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.

DISEASE CHARACTERISTICS:

• Histologically confirmed renal cell carcinoma

• Metastatic disease requiring first-line treatment with sunitinib malate

  • No prior therapy for metastatic disease

• No symptomatic or uncontrolled cerebral metastasis

PATIENT CHARACTERISTICS:

• Affiliation to the French Social insurance
• Life expectancy ≥ 3 months
• No heart failure
• No chronic unstable disease
• No long QT interval
• No history of another primary cancer
• No severe, uncontrolled acute infection
• No severe, uncontrolled hypertension
• No psychological disorder

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics