Sunitinib Malate in Treating Patients With Kidney Cancer

Kidney Cancer Clinical Trial

Official title:

Effects of Sunitinib in the Expression of VEGF and of Interleukin 6 and CXCL7 - CXCL5 Cytokins : Explanation of Anti-angiogenic Effects.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00943839
• Other study ID #: CDR0000638415
• Secondary ID: CALACASS-SUVEGIL
• Status: Completed
• Phase: N/A
• First received: July 21, 2009
• Last updated: November 9, 2016
• Start date: February 2009
• Est. completion date: December 2014

Study information

• Verified date: November 2015
• Source: Centre Antoine Lacassagne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Cancer
• Kidney Neoplasms

Intervention

Drug:
• sunitinib malate

Other:
• laboratory biomarker analysis

• pharmacological study

Locations

Country	Name	City	State
France	Centre Antoine Lacassagne	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Antoine Lacassagne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease response		5 years	Yes
Primary	VEGF and IL-8 blood levels determined before and every 6 weeks during treatment		5 years	No
Secondary	Length of the response		up to 5 years	No
Secondary	Disease-free survival		up to 5 years	No
Secondary	Overall survival		up to 5 years	No