NCT00943839

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Centre Antoine Lacassagne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
DRUG	sunitinib malate
OTHER	laboratory biomarker analysis
OTHER	pharmacological study

Timeline

• Start date: 2009-02-01
• Primary completion: 2014-11-01
• Completion: 2014-12-01
• First posted: 2009-07-22
• Last updated: 2016-11-10

Locations

1 site across 1 country: France