Full Text View
Tabular View
No Study Results Posted
Related Studies
XENOX – Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy
This study has been completed.
First Received: January 3, 2006   Last Updated: September 11, 2006   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00272051
  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 III

Study Type: Interventional
Study Design: Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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-Aventis:

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00272051

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

Additional Information:
No publications provided

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

Keywords provided by Sanofi-Aventis:
Neurotoxicity syndromes
Paresthesia
Oxaliplatin
Xaliproden

Study placed in the following topic categories:
Digestive System Neoplasms
Neurotoxicity Syndromes
Gastrointestinal Diseases
Colonic Diseases
Poisoning
Disorders of Environmental Origin
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Carcinoma
Oxaliplatin
Digestive System Diseases
Fluorouracil
Paresthesia
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Gastrointestinal Diseases
Antineoplastic Agents
Colonic Diseases
Disorders of Environmental Origin
Rectal Diseases
Neoplastic Processes
Oxaliplatin
Neoplasms by Site
Pathologic Processes
Therapeutic Uses
Neoplasm Metastasis
Digestive System Neoplasms
Neoplasms by Histologic Type
Nervous System Diseases
Poisoning
Intestinal Diseases
Intestinal Neoplasms
Pharmacologic Actions
Carcinoma
Neoplasms
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 01, 2009