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Sunitinib Malate in Treating Patients With Kidney Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00943839
First Posted: July 22, 2009
Last Update Posted: November 10, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Antoine Lacassagne
  Purpose

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.


Condition Intervention
Kidney Cancer Drug: sunitinib malate Other: laboratory biomarker analysis Other: pharmacological study

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Sunitinib in the Expression of VEGF and of Interleukin 6 and CXCL7 - CXCL5 Cytokins : Explanation of Anti-angiogenic Effects.

Resource links provided by NLM:


Further study details as provided by Centre Antoine Lacassagne:

Primary Outcome Measures:
  • Disease response [ Time Frame: 5 years ]
  • VEGF and IL-8 blood levels determined before and every 6 weeks during treatment [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Length of the response [ Time Frame: up to 5 years ]
  • Disease-free survival [ Time Frame: up to 5 years ]
  • Overall survival [ Time Frame: up to 5 years ]

Estimated Enrollment: 60
Study Start Date: February 2009
Study Completion Date: December 2014
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SUVEGIL Drug: sunitinib malate Other: laboratory biomarker analysis Other: pharmacological study

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00943839


Locations
France
Centre Antoine Lacassagne
Nice, France, 06189
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Principal Investigator: Jean Marc Ferrero, MD Centre Antoine Lacassagne
  More Information

Responsible Party: Centre Antoine Lacassagne
ClinicalTrials.gov Identifier: NCT00943839     History of Changes
Other Study ID Numbers: CDR0000638415
CALACASS-SUVEGIL-8
2008/20
INCA-RECF0943
EUDRACT-2008-004137-21
First Submitted: July 21, 2009
First Posted: July 22, 2009
Last Update Posted: November 10, 2016
Last Verified: November 2015

Keywords provided by Centre Antoine Lacassagne:
stage IV renal cell cancer

Additional relevant MeSH terms:
Kidney Neoplasms
Carcinoma, Renal Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Sunitinib
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors