Sunitinib Malate in Treating Patients With Kidney Cancer
Conditions
Kidney Cancer
Conditions: official terms
Carcinoma, Renal Cell - Kidney Neoplasms
Conditions: Keywords
stage IV renal cell cancer
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: sunitinib malate Type: Drug
Name: laboratory biomarker analysis Type: Other
Name: pharmacological study Type: Other
Overall Status
Recruiting
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-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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
Centre Antoine Lacassagne
Nice, France
Status: Recruiting
Contact: Jean Marc Ferrero, MD - 33-4-9203-1114 - jean-marc.ferrerero@nice.fnclcc.fr
Start Date
February 2009
Completion Date
December 2014
Sponsors
Centre Antoine Lacassagne
Source
Centre Antoine Lacassagne
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page