Sunitinib Malate in Treating Patients With Kidney Cancer
Primary Purpose
Kidney Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
sunitinib malate
laboratory biomarker analysis
pharmacological study
Sponsored by
About this trial
This is an interventional treatment trial for Kidney Cancer focused on measuring stage IV renal cell cancer
Eligibility Criteria
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
Sites / Locations
- Centre Antoine Lacassagne
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SUVEGIL
Arm Description
Outcomes
Primary Outcome Measures
Disease response
VEGF and IL-8 blood levels determined before and every 6 weeks during treatment
Secondary Outcome Measures
Length of the response
Disease-free survival
Overall survival
Full Information
NCT ID
NCT00943839
First Posted
July 21, 2009
Last Updated
November 9, 2016
Sponsor
Centre Antoine Lacassagne
1. Study Identification
Unique Protocol Identification Number
NCT00943839
Brief Title
Sunitinib Malate in Treating Patients With Kidney Cancer
Official Title
Effects of Sunitinib in the Expression of VEGF and of Interleukin 6 and CXCL7 - CXCL5 Cytokins : Explanation of Anti-angiogenic Effects.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Antoine Lacassagne
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Cancer
Keywords
stage IV renal cell cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SUVEGIL
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Other
Intervention Name(s)
pharmacological study
Primary Outcome Measure Information:
Title
Disease response
Time Frame
5 years
Title
VEGF and IL-8 blood levels determined before and every 6 weeks during treatment
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Length of the response
Time Frame
up to 5 years
Title
Disease-free survival
Time Frame
up to 5 years
Title
Overall survival
Time Frame
up to 5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Marc Ferrero, MD
Organizational Affiliation
Centre Antoine Lacassagne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
29563634
Citation
Polena H, Creuzet J, Dufies M, Sidibe A, Khalil-Mgharbel A, Salomon A, Deroux A, Quesada JL, Roelants C, Filhol O, Cochet C, Blanc E, Ferlay-Segura C, Borchiellini D, Ferrero JM, Escudier B, Negrier S, Pages G, Vilgrain I. The tyrosine-kinase inhibitor sunitinib targets vascular endothelial (VE)-cadherin: a marker of response to antitumoural treatment in metastatic renal cell carcinoma. Br J Cancer. 2018 May;118(9):1179-1188. doi: 10.1038/s41416-018-0054-5. Epub 2018 Mar 22.
Results Reference
derived
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Sunitinib Malate in Treating Patients With Kidney Cancer
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