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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00272051
First received: January 3, 2006
Last updated: September 11, 2006
Last verified: September 2006
  Purpose

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
Metastases
Colorectal Neoplasms
Colorectal Carcinoma
Drug: SR57746A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00272051

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00272051     History of Changes
Other Study ID Numbers: EFC4972, SR57746A
Study First Received: January 3, 2006
Last Updated: September 11, 2006
Health Authority: United Kingdom: National Health Service

Keywords provided by Sanofi:
Neurotoxicity syndromes
Paresthesia
Oxaliplatin
Xaliproden

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Carcinoma
Colorectal Neoplasms
Chemically-Induced Disorders
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Nervous System Diseases
Poisoning
Rectal Diseases
Oxaliplatin
Antineoplastic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014