Evaluation of the Efficacy of Xaliproden (SR57746A) in Preventing the Neurotoxicity of Oxaliplatin / 5FU/LV Chemotherapy.

Inclusion Criteria: Main inclusion criteria : Histologically or cytologically-proven metastatic cancer of the colon or rectum. Metastatic disease not amenable to potentially curative treatment (eg: inoperable metastatic disease). Male or female aged >18 years. WHO Performance Status (PS) : 0 or 1. Measurable disease. No prior chemotherapeutic regimen for metastatic disease. Disease-free interval from end of adjuvant therapy of at least 6 months (1 year if oxaliplatin was part of the adjuvant therapy). Prior radiotherapy is permitted if it was not administered to target lesions identified for this study - unless progression within the radiation portal is documented - and provided it has been completed at least 3 weeks before randomization. Signed written informed consent prior to study entry. Exclusion Criteria: Main exclusion criteria : Any condition or past medical history that contra-indicates treatment with oxaliplatin and 5-FU, as reported in approved labeling information. Received chemotherapeutic agents other than 5-FU, LV, Levamisole, irinotecan, capecitabine, oxaliplatin as part of adjuvant therapy. Peripheral neuropathy >Grade 1. Concomitant treatments with drugs/ingredients reported to have a potential activity in preventing peripheral sensory neuropathy. Concurrent active cancer originating from a primary site other than colon or rectum. Presence of any symptom suggesting brain metastasis.