Phase II study of oxaliplatin, 5-fluorouracil, and leucovorin in relapsed or metastatic colorectal cancer as second line therapy.

PURPOSE The purpose of the study was to assess the efficacy and safety of biweekly oxaliplatin in combination with leucovorin (LV)-modulated bolus plus infusion of 5-fluorouracil (5-FU) in patients with relapsed or metastatic colorectal cancer (CRC) as a second line therapy. MATERIALS AND METHODS Between November 2002 and October 2005, 26 patients with histologically confirmed relapsed or metastatic CRC were enrolled. All patients were previously treated with irinotecan-based combination chemotherapy. The chemotherapy regimen consisted of oxaliplatin 85 mg/m(2) on day 1; LV 200 mg/m(2) on days 1 and 2; and 5-FU 400 mg/m(2) bolus IV with 600 mg/m(2) with a 22-hour infusion on days 1 and 2 every 2 weeks. RESULTS The median age of the 26 patients was 50.5 years (range, 31 approximately 72). Their metastatic sites included: the liver (42.3%), peritoneum (26.9%), lung (23.1%) and ovary (7.7%). Twenty five patients were evaluated for their response. Four patients achieved partial responses and 15 patients had stable disease. The overall response rate was 16% (95% confidence interval; 1.7 approximately 30.3%). The median follow-up duration for the surviving patients was 7.4 months (range, 2.08 approximately 21.2). Median overall survival (OS) and 1-year OS rates were 16.7 months and 63.9%, respectively. The most common hematological toxicities were: NCI grade I/II leucopenia (49.3%), grade I/II neutropenia (41%) and grade I/II anemia (65.2%). The main non-hematological toxicities were: grade I/II peripheral neuropathy (16.1% and 21.5%, respectively) and nausea/vomiting (23.6%/18.5%). There was no life-threatening toxicity. CONCLUSION The oxaliplatin, 5-FU and LV combination chemotherapy, scheduled as a biweekly protocol, was effective and well tolerated in the treatment of relapsed or metastatic colorectal cancer patients as second line chemotherapy.