Sunitinib Malate in Treating Patients With Kidney Cancer
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|ClinicalTrials.gov Identifier: NCT00943839|
Recruitment Status : Completed
First Posted : July 22, 2009
Last Update Posted : November 10, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Kidney Cancer||Drug: sunitinib malate Other: laboratory biomarker analysis Other: pharmacological study||Not Applicable|
- 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-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 (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of Sunitinib in the Expression of VEGF and of Interleukin 6 and CXCL7 - CXCL5 Cytokins : Explanation of Anti-angiogenic Effects.|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||November 2014|
|Actual Study Completion Date :||December 2014|
Drug: sunitinib malate
Other: laboratory biomarker analysis
Other: pharmacological study
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943839
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Principal Investigator:||Jean Marc Ferrero, MD||Centre Antoine Lacassagne|