Triplet schedule of weekly 5-Fluorouracil and alternating irinotecan or oxaliplatin in advanced colorectal cancer: A dose-finding and phase II study

M. F. Morelli, A. Santomaggio, E. Ricevuto, K. Cannita, F. De Galitiis, M. Tudini, G. Bruera, M. Mancini, M. Pelliccione, F. Calista, F. Guglielmi, F. Martella, P. Lanfiuti Baldi, G. Porzio, A. Russo, N. Gebbia, S. Iacobelli, P. Marchetti, Corrado Ficorella

Research output: Contribution to journalArticlepeer-review

Abstract

A weekly administration of alternating irinotecan or oxaliplatin associated to 5-Fluorouracil in advanced colorectal cancer was planned in order to evaluate a new schedule maintaining dose intensities of each drug as in double combinations and tolerability of the triplet association. The following weekly schedule was administered: irinotecan, days 1 and 15; oxaliplatin, days 8 and 22; 5-fluorouracil (5-FU) over 12-h (from 10:00 p.m. to 10:00 a.m.) timed flat infusion, days 1-2, 8-9, 15-16 and 22-23, every 4 weeks. Dosefinding and phase II study were planned. Thirteen patients were enrolled in the dose-finding study and 23 in the phase II study. The recommended doses of our study are: irinotecan 160 mg/m2; oxaliplatin 80 mg/m2; 5-FU 900 mg/m2. The doselimiting toxicity was diarrhea (35% of patients) but no cases of febrile neutropenia were observed. In 30 patients assessable for response two complete (6.7%) and 18 partial (60%) responses were observed, for an overall response rate of 66.7% (α0.05, CI±7). The triplet association using this weekly alternating schedule is an active and well-tolerated outpatient regimen. Surgical removal of residual disease was considered in 5 patients and a radical resection was performed in 5 patients (14%).

Original languageEnglish
Pages (from-to)1635-1640
Number of pages6
JournalOncology Reports
Volume23
Issue number6
DOIs
Publication statusPublished - 2010

Keywords

  • 5-Fluorouracil
  • Advanced colorectal cancer
  • CPT-11
  • l-OHP

ASJC Scopus subject areas

  • Cancer Research
  • Oncology
  • Medicine(all)

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