OBJECTIVE To investigate the efficiency and safety of the oxaliplatin,fluorouracil (5-FU) and leucovorin regimen (FOLFOX) in previously untreated patients with metastatic or recurrent colorectal cancer.METHODS Previously untreated patients with metastatic or recurrent colorectal cancer received 100 mg/m2 of oxaliplatin intravenously (Ⅳ) over 2 h on day 1, and Ⅳ 400 mg/m2 of leucovorin over 2 h followed by a bolus of 400 mg/m2 of 5-FU. Then 2,600～3,000 mg/m2 of 5-FU was administered by continuous infusion over 46 h.RESULTS An evaluated response rate was determined for 97 of 105 treated patients. The overall response rate was 35.1%, 9 patients (9.3%)had a complete response and 25 patients (25.8%) a partial response. Thirtytwo patients (33.0%) developed stable disease and 32.0% of the patients progressed. The median time to progression (TTP) was 7.7 months and the median overall survival 20.5 months. One and 2-year survival rates were 68% and 32%. Toxic effects based on the National Cancer Institute-Common Toxicity Criteria (NCI-CTC), reaching grade 3/4 were: neutropenia 12.3%,anemia 11.3%, vomiting 4.1% and diarrhea 7.2%. Grade 3 neuropathy was 5.1%. The overall survival rate of patients who had received a radical resection was superior to the patients who had not received a operation, or had received a palliative resection (P=0.0658). The serum levels of CEA, ALP and LDH had no relationship with survival (P＞0.05).CONCLUSION The FOLFOX regimen containing oxaliplatin, 5-FU plus leucovorin was an efficacious regimen with good tolerability in previously untreated metastatic or recurrent colorectal cancer patients.