XENOX - Evaluation of the Efficacy of Xaliproden in Reducing the Neurotoxicity of the Oxaliplatin + 5-FU/LV Chemotherapy
Status:
Completed
Trial end date:
2004-05-01
Target enrollment:
Participant gender:
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.