Weekly chronomodulated 48 h infusion of high-dose 5-fluorouracil modulated by methotrexate and (6S)-leucovorin in advanced colorectal cancer: a phase IB study

Anticancer Drugs. 1997 Jun;8(5):454-8. doi: 10.1097/00001813-199706000-00006.

Abstract

In this phase IB study, 24 patients with advanced colorectal cancer were treated with escalating doses of weekly chronomodulated 48 h infusions of 5-fluorouracil (5-FU) biochemically modulated by methotrexate 40 mg/m2 and (6S)-leucovorin 8 x 45 mg orally. Two daily peak delivery periods (PDP), during which 65% of the daily dose was administered, were investigated: from 18.00 to 0.30 h and from 0.00 to 06.30 h. The maximal tolerated dose of 5-FU was 2800 mg/m2/48 h, with a PDP from 18.00 to 0.30 h.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adenocarcinoma / drug therapy*
  • Adenocarcinoma / pathology
  • Adult
  • Aged
  • Antidotes / administration & dosage*
  • Antidotes / therapeutic use*
  • Antimetabolites, Antineoplastic / administration & dosage*
  • Antimetabolites, Antineoplastic / adverse effects
  • Antimetabolites, Antineoplastic / therapeutic use*
  • Clinical Trials, Phase I as Topic
  • Colorectal Neoplasms / drug therapy*
  • Colorectal Neoplasms / pathology
  • Female
  • Fluorouracil / administration & dosage*
  • Fluorouracil / adverse effects
  • Fluorouracil / therapeutic use*
  • Humans
  • Infusions, Intravenous
  • Leucovorin / administration & dosage*
  • Leucovorin / therapeutic use*
  • Male
  • Methotrexate / administration & dosage*
  • Methotrexate / therapeutic use*
  • Middle Aged
  • Time Factors

Substances

  • Antidotes
  • Antimetabolites, Antineoplastic
  • Leucovorin
  • Fluorouracil
  • Methotrexate