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

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.