Oxaliplatin combined with irinotecan and 5-fluorouracil/leucovorin (OCFL) in metastatic colorectal cancer: A phase I-II study

Y. Seium, R. Stupp, T. Ruhstaller, P. Gervaz, G. Mentha, M. Philippe, A. Allal, C. Trembleau, J. Bauer, R. Morant, Arnaud D. Roth*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

62 Scopus citations


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 (30mg) 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/m2/24h. 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.

Original languageEnglish (US)
Pages (from-to)762-766
Number of pages5
JournalAnnals of Oncology
Issue number5
StatePublished - May 2005


  • Colorectal cancer
  • Irinotecan
  • Oxaliplatin
  • Triplet regimen

ASJC Scopus subject areas

  • Hematology
  • Oncology


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