Sunitinib Malate in Treating Patients With Kidney Cancer
NCT ID: NCT00943839
Last Updated: 2016-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2009-02-28
2014-12-31
Brief Summary
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PURPOSE: This clinical trial is studying how well sunitinib malate works in treating patients with kidney cancer.
Detailed Description
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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
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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SUVEGIL
sunitinib malate
laboratory biomarker analysis
pharmacological study
Interventions
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sunitinib malate
laboratory biomarker analysis
pharmacological study
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Centre Antoine Lacassagne
OTHER
Responsible Party
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Principal Investigators
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Jean Marc Ferrero, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Antoine Lacassagne
Locations
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Centre Antoine Lacassagne
Nice, , France
Countries
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References
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Montemagno C, Durivault J, Gastaldi C, Dufies M, Vial V, He X, Ambrosetti D, Kamenskaya A, Negrier S, Bernhard JC, Borchiellini D, Cao Y, Pages G. A group of novel VEGF splice variants as alternative therapeutic targets in renal cell carcinoma. Mol Oncol. 2023 Jul;17(7):1379-1401. doi: 10.1002/1878-0261.13401. Epub 2023 Apr 18.
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.
Other Identifiers
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CALACASS-SUVEGIL-8
Identifier Type: -
Identifier Source: secondary_id
2008/20
Identifier Type: -
Identifier Source: secondary_id
INCA-RECF0943
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2008-004137-21
Identifier Type: -
Identifier Source: secondary_id
CDR0000638415
Identifier Type: -
Identifier Source: org_study_id