Effects of Sunitinib in the Expression of VEGF and of Interleukin 8: Explanation of Anti-angiogenic Effects.
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-8 blood levels in these patients.
- To evaluate the link between VEGF and IL-8 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-8 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.
Interventional
Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment
Disease response
No
Jean Marc Ferrero, MD
Principal Investigator
Centre Antoine Lacassagne
Unspecified
CDR0000638415
NCT00943839
February 2009
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