Sunitinib Malate in Treating Patients With Kidney Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Kidney Cancer

Intervention / Treatment
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* Drug: sunitinib malate
* Other: laboratory biomarker analysis
* Other: pharmacological study


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SUVEGIL<br> | Drug: sunitinib malate<br> <br> Other: laboratory biomarker analysis<br> <br> Other: pharmacological study<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease response |  | 5 years | 
| VEGF and IL-8 blood levels determined before and every 6 weeks during treatment |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of the response |  | up to 5 years | 
| Disease-free survival |  | up to 5 years | 
| Overall survival |  | up to 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV renal cell cancer