Original Article A Multicenter Phase-II Study of 5-FU, Leucovorin and Oxaliplatin (FOLFOX6) in Patients with Pretreated Metastatic Colorectal Cancer

Objective: Infusional 5-fluorouracil and leucovorin with oxaliplatin is one of the standard regi-mens for patients with pretreated metastatic colorectal cancer, as well as for first-line che-motherapy. FOLFOX4 has shown its efficacy in pivotal trials, but patients must make twice-weekly hospital visits. FOLFOX6 is a more convenient regimen, requiring a visit once every two weeks. The objective of this study was to evaluate the efficacy and safety profile of FOLFOX6 in Japanese patients with pretreated colorectal cancer. Method: Fifty-one metastatic colorectal cancer patients who failed to respond to first-line che-motherapy were enrolled in the study from April to July 2005. Oxaliplatin, 5-fluorouracil and l-leucovorin were administered every two weeks. Oxaliplatin (100 mg/m2) and l-leucovorin (200 mg/m2) were given intravenously over 2 h followed by 5-fluorouracil bolus 400 mg/m2 i.v. and 46-h infusion of 2400 mg/m2. The primary endpoint was the response rate. Results: Two patients had no measurable lesions and were excluded from the efficacy analy-sis. Of the 49 eligible patients, one complete response and 6 partial responses wer