A Multicenter, Randomized Double-blind Placebo Controlled Phase III Study of the Efficacy of Xaliproden in Preventing the Neurotoxicity of Oxaliplatin in First-line Treatment of Patients With Metastatic Colorectal Cancer Treated With Oxaliplatin / 5-FU/LV

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.