Role of Xaliproden on Recovery Rate From Severe Neuropathy in Patients Who Have Completed Adjuvant Chemotherapy With Oxaliplatin Based Regimens

Inclusion Criteria:

• Have completed an oxaliplatin-containing chemotherapy regimen post complete surgicalremoval of primary colon tumor no later than 6 weeks before randomization;

• Have Grade ≥ 1 PSN, as defined by the NCI-CTCAE version 3.0

• Have an Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2;

• Blood tests within 14 days prior to randomization: (a) AST (SGOT) and ALT (SGPT) ≤2 xupper limit of normal (ULN); (b) serum creatinine ≤1.5 x ULN; (c)HbA1c ≤7%; (d)neutrophils ≥1.5x10^9/L ; (e) platelets ≥50x10^9/L; (f) Serum D-dimer within normallimits

Exclusion Criteria:

• Pre-existing peripheral neuropathy prior to treatment with oxaliplatin

• Receiving any further anti-cancer treatment

• History of any recent (≤1 year) thrombo-embolic events and current clinical evidenceof thrombo-embolism

• Unstable cardiac disease

• History of significant neurological or psychiatric disorders including dementia orseizures,

• Active uncontrolled infection

• Active disseminated intravascular coagulation

• Other serious underlying medical conditions which could impair the ability of thepatient to participate in the study;

• Use of antidepressant/antiepileptic medication (for the treatment of PSN), unlesscommenced before informed consent form signed. The addition of these medications (forthe treatment of PSN) once the patient has consented is not allowed

• Concurrent treatment with any other experimental drugs

• Pregnant or breast-feeding women;

• Women of childbearing potential must be protected by effective contraceptive methodsof birth control. Post-menopausal women must have been amenorrheic for at least 12months to be considered as having non-childbearing potential

• Any psychological, familial, sociological or geographical condition potentiallyhampering compliance with the study protocol and follow-up schedule. Those conditionsshould be assessed with the patient before registration in the trial. The above information is not intended to contain all considerations relevant to a patient'spotential participation in a clinical trial.