Clinical trial NCT00943839: 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
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Cancer
Keywords: stage IV renal cell cancer
Lead sponsor: Centre Antoine Lacassagne
Sponsor class: OTHER
First posted: 2009-07-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disease response
timeFrame: 5 years
measure: VEGF and IL-8 blood levels determined before and every 6 weeks during treatment
timeFrame: 5 years
Secondary outcomes:
measure: Length of the response
timeFrame: up to 5 years
measure: Disease-free survival
timeFrame: up to 5 years
measure: Overall survival
timeFrame: up to 5 years
Other outcomes:
Locations:
city: Nice
country: France
facility: Centre Antoine Lacassagne
Study officials:
affiliation: Centre Antoine Lacassagne
name: Jean Marc Ferrero, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.