Sunitinib Malate in Treating Patients With Kidney Cancer

Not Applicable

Completed

• Conditions: Kidney Cancer
• Interventions: Drug: sunitinib malate; Other: laboratory biomarker analysis; Other: pharmacological study

• Registration Number: NCT00943839
• Lead Sponsor: Centre Antoine Lacassagne

Brief 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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-07-21
• Study First Submitted QC: 2009-07-21
• Study First Posted: 2009-07-22
• Primary Completion: 2014-11
• Study Completion: 2014-12
• Status Verified: 2015-11
• Last Update Submitted: 2016-11-09
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SUVEGIL	laboratory biomarker analysis	-
SUVEGIL	pharmacological study	-
SUVEGIL	sunitinib malate	-

Primary Outcome Measures

Name	Time	Method
Disease response	5 years
VEGF and IL-8 blood levels determined before and every 6 weeks during treatment	5 years

Secondary Outcome Measures

Name	Time	Method
Length of the response	up to 5 years
Disease-free survival	up to 5 years
Overall survival	up to 5 years

Trial Locations

Locations (1)

Centre Antoine Lacassagne; 🇫🇷 Nice, France