Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Sunitinib Malate in Treating Patients With Kidney Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2012 by Centre Antoine Lacassagne
Sponsor:
Information provided by (Responsible Party):
Centre Antoine Lacassagne
ClinicalTrials.gov Identifier:
NCT00943839
First received: July 21, 2009
Last updated: November 20, 2014
Last verified: August 2012
  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
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Sunitinib in the Expression of VEGF and of Interleukin 8: 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 ] [ Designated as safety issue: Yes ]
  • VEGF and IL-8 blood levels determined before and every 6 weeks during treatment [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of the response [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Disease-free survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2009
Estimated 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-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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00943839

Locations
France
Centre Antoine Lacassagne Recruiting
Nice, France, 06189
Contact: Jean Marc Ferrero, MD    33-4-9203-1114    jean-marc.ferrerero@nice.fnclcc.fr   
Sponsors and Collaborators
Centre Antoine Lacassagne
Investigators
Principal Investigator: Jean Marc Ferrero, MD Centre Antoine Lacassagne
  More Information

Additional Information:
No publications provided

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
Study First Received: July 21, 2009
Last Updated: November 20, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

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

ClinicalTrials.gov processed this record on November 27, 2014