Safety & tolerability of FOLFOX4 regimen in the adjuvant treatment of colon cancer in Asian patients

Inclusion Criteria:

• Histologically proven stage Dukes " B2 " (stage II: T3-T4 N0 M0) and " C " (stage III: any T N1-2 M0) colon carcinoma. The inferior pole of the tumor must be above the peritoneal reflection (> 15 cm from the anal margin).
• Patients must have undergone complete resection of the primary tumor without gross or microscopic evidence of residual disease
• Patients must be entered in the study in order to start treatment within 7 weeks after surgery
• Age 18-75 years old
• Performance Status ≤ 2 (Karnofsky > or = 60%)
• No previous chemotherapy, immunotherapy or radiotherapy
• No biological major abnormalities :Absolute neutrophil count > 1.5 x 10^9/l,Platelets ≥ 100 x 10^9/l,Serum creatinine ≤ 1.25 times the upper limit of normal, total bilirubin, ASAT / ALAT < 2 times the upper limit of the normal range,carcinoembryonic antigen < 10 ng/ml.
• Documentation of a negative pregnancy test must be available for premenopausal women with intact reproductive organs
• Men and women who are fertile must use a medically acceptable contraceptive throughout the treatment period and for 3 months following cessation of treatment with oxaliplatin. Subjects must be made aware, before entering this trial of the risk of becoming pregnant or in fathering children
• Signed informed consent obtained prior to study entry

Exclusion criteria

• Pregnant or lactating women
• Women of child bearing potential not using a contraceptive method
• Previous cancer of the colon or rectum
• Previous malignancies other than adequately treated in situ carcinoma of the uterine cervix or basal or squamous cell carcinoma of the skin, unless there has been a disease-free interval of at least 10 years
• Participation in another clinical trial with any investigational drug within 30 days prior to randomization
• Peripheral neuropathy (NCI CTC [National Cancer Institute Common Toxicity Criteria] > or = Grade I)
• Uncontrolled congestive heart failure or angina pectoris, or hypertension or arrhythmia
• History of significant neurologic or psychiatric disorders
• Active infection

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.