Randomised phase II study of standard versus chronomodulated CPT-11 plus chronomodulated 5-fluorouracil and folinic acid in advanced colorectal cancer patients

Carlo Garufi, Barbara Vanni, Anna Maria Aschelter, Albina Rita Zappalà, Emilio Bria, Cecila Nisticò, Isabella Sperduti, Francesco Cognetti, Edmondo Terzoli

Research output: Contribution to journalArticlepeer-review

Abstract

In this study, a randomised phase II trial explored the effects of 6-h chronomodulated CPT-11 infusion in advanced colorectal cancer patients. Sixty-eight pre-treated patients were randomly assigned to CPT-11 administered at 180 mg/m2 on day 1, by 1-h infusion (Arm A) or 6-h sinusoidal infusion with peak timing at 5:00 a.m. (Arm B). All patients also received chronomodulated folinic acid/5-fluorouracil (FA/5-FU). Patients in Arm B obtained a 25.7% response rate for 7.0 months duration, a progression-free survival for 8.0 months and a median survival of 28 months. The same data in Arm A were 18.2%, 4.5, 6.0 and 18 months, respectively. No differences in drugs dose-intensity or increased toxicity with prolonged chronomodulated infusion were detected. Major grade 3-4 toxicity was diarrhoea: 10 patients in Arm A and 13 in Arm B. In conclusion, this study has shown that chronomodulated infusion of CPT-11 and FA/5-FU is safe, active and can be integrated with oxaliplatin (EORTC 05011) for the treatment of advanced colorectal cancer.

Original languageEnglish
Pages (from-to)608-616
Number of pages9
JournalEuropean Journal of Cancer
Volume42
Issue number5
DOIs
Publication statusPublished - Mar 2006

Keywords

  • 5-Fluorouracil
  • Chronomodulation
  • Colorectal cancer
  • Irinotecan

ASJC Scopus subject areas

  • Cancer Research
  • Hematology
  • Oncology

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