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.