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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: January 3, 2006
Last updated: September 11, 2006
Last verified: September 2006
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.

Condition Intervention Phase
Colorectal Neoplasms
Colorectal Carcinoma
Drug: SR57746A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Clinical evaluation of peripheral sensory neuropathy using the Oxaliplatin specific scale for dose adjustment : Q2W ; response rate using RECIST criteria : Q8W

Secondary Outcome Measures:
  • Safety : Q2W ; Nerve conduction studies : Baseline + cycle 12 ; Progression Free Survival : Q8W ; Survival

Estimated Enrollment: 620
Study Start Date: July 2002
Estimated Study Completion Date: May 2004

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00272051

Sponsors and Collaborators
Study Chair: Gérard SAID, MD Hôpital de Bicêtre - Le Kremlin-Bicêtre - France
  More Information

Additional Information: Identifier: NCT00272051     History of Changes
Other Study ID Numbers: EFC4972
Study First Received: January 3, 2006
Last Updated: September 11, 2006

Keywords provided by Sanofi:
Neurotoxicity syndromes

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Nervous System Diseases
Chemically-Induced Disorders
Antineoplastic Agents processed this record on April 28, 2017