Annals of Oncology Advance Access originally published online on April 7, 2005
Annals of Oncology 2005 16(5):762-766; doi:10.1093/annonc/mdi154
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© 2005 European Society for Medical Oncology
Oxaliplatin combined with irinotecan and 5-fluorouracil/leucovorin (OCFL) in metastatic colorectal cancer: a phase I–II study
1 Oncosurgery, Services of 2Visceral Surgery and 3 Radiooncology, Geneva University Hospital, Geneva; 4 University Hospital (CHUV), Multidisciplinary Oncology Center, Lausanne; 5 Kantonspital St. Gallen, Division of Oncology, Department of Medicine C, St. Gallen; 6 Zetup Clinic, St. Gallen, Switzerland
* Correspondence to: Dr A. D. Roth, Geneva University Hospital, Oncosurgery, Geneva, Switzerland. Email: arnaud.roth{at}sim.hcuge.ch
Background:: A phase I–II multicenter trial was conducted to define the maximal tolerated dose and describe the activity of an OCFL combination using oxaliplatin (OHP), irinotecan (CPT-11) and 5-fluorouracil (FU)/leucovorin (LV) in metastatic colorectal cancer (CRC).
Patients and methods:: CRC patients not pretreated with palliative chemotherapy, with performance status 
1 and adequate haematological, kidney and liver function, were eligible. Treatment consisted in weekly 24-h infusion 5-FU (2300 mg/m2)/LV (30 mg) and alternating OHP (70–85 mg/m2, days 1 and 15) and CPT-11 (80–140 mg/m2, days 8 and 22) repeated every 5 weeks. OHP and CPT-11 were escalated in cohorts of three to six patients.
Results:: Thirty patients received a median of five cycles. Dose-limiting toxicity occurred at dose level 3, and the recommended dose was OHP 70 mg/m2, CPT-11 100 mg/m2, LV 30 mg and 5-FU 2300 mg/m2/24 h. Grade 
3 toxicities were diarrhea 23%, neutropenia 20%, fatigue 7%, and neurologic 7%. Two febrile neutropenia episodes (one fatal) were recorded. Among 28 patients with measurable disease (90%), we observed two complete and 20 partial responses; overall RR was 78% (95% CI, 59% to 92%). Median time to progression and overall survival were 9.5 and 25.4 months, respectively. Seven patients underwent liver metastases resection.
Conclusion:: OCFL is an overall well tolerated regimen with very high efficacy, which makes it most suitable for tumour control before surgery of metastatic disease.
Key words: colorectal cancer, irinotecan, oxaliplatin, triplet regimen
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