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XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy

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ClinicalTrials.gov Identifier: NCT00272051
Recruitment Status : Completed
First Posted : January 4, 2006
Last Update Posted : September 13, 2006
Sponsor:
Information provided by:
Sanofi

Tracking Information
First Submitted Date  ICMJE January 3, 2006
First Posted Date  ICMJE January 4, 2006
Last Update Posted Date September 13, 2006
Study Start Date  ICMJE July 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2006)
Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment : Q2W ; response rate using RECIST criteria : Q8W
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2006)
Safety : Q2W ; Nerve conduction studies : Baseline + cycle 12 ; Progression Free Survival : Q8W ; Survival
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy
Official Title  ICMJE A Multicenter Randomized Dble-Blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin and 5-FU/LV Combination in First-Line Treatment of Patients With Metastatic Colorectal Carcinoma(MCRC)
Brief Summary Purpose of the trial is to evaluate the efficacy of Xaliproden in reducing the neurotoxicity of the Oxaliplatin and 5-FU/LV chemotherapy, in patients with metastatic colorectal carcinomaPrimary objectives : Compare the risk of occurence of grade 3-4 peripheral sensory neuropathy relative to the cumulative dose of Oxaliplatin between treatment group and placebo group ; Compare the response rate between treatment group and placebo group.Secondary objectives : neurotoxicity parameters (overall incidence, time and dose to onset, time to recovery, change in the sensory action potentials) ; antitumoral efficacy (progression-free survival, overall survival) ; safety profile.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Condition  ICMJE
  • Metastases
  • Colorectal Neoplasms
  • Colorectal Carcinoma
Intervention  ICMJE Drug: SR57746A
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: January 3, 2006)
620
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE May 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically or cytologically proven adenocarcinoma of the colon or the rectum
  • age > 18 years
  • WHO performance status : 0,1,2
  • Signed written informed consent prior to study entry
  • Disease stage : metastatic disease not amenable to potentially curative treatment (eg : inoperable metastatic disease)
  • Measurable disease
  • No prior chemotherapeutic regimen for metastatic disease ; prior adjuvant chemotherapy allowed (disease free interval from end of adjuvant therapy of at least 6 months)
  • Prior radiotherapy permitted, if completed at least 3 weeks before randomization, and if not administered to target lesions identified for the study

Exclusion Criteria:

  • Chemotherapeutic agents other than 5-FU/LV or 5-FU/Levamizole as part of adjuvant therapy
  • Prior therapy with Oxaliplatin
  • History of cardiac toxicities under 5-FU/LV therapy or myocardial infarction within the 6 months before study entry ; Known Dihydropyrimidine Dehydrogenase deficiency
  • History of intolerance to appropriate antiemetics
  • Concurrent active cancer originating from a primary site other than colon or rectum
  • Presence of any symptom suggesting brain metastasis
  • Known peripheral neuropathy
  • Interstitial pneumonia or extensive and symptomatic fibrosis of the lung
  • Allergy to Xaliproden/excipients
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00272051
Other Study ID Numbers  ICMJE EFC4972
SR57746A
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Gérard SAID, MD Hôpital de Bicêtre - Le Kremlin-Bicêtre - France
PRS Account Sanofi
Verification Date September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP