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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Colorectal Carcinoma

Metastases

Colorectal Neoplasms

Treatments

Drug: SR57746A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00272051

EFC4972

SR57746A

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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