Phase I study of a 120-hour continuous intravenous infusion of 5-fluorouracil in pediatric patients with recurrent solid tumors: a Pediatric Oncology Group study

Med Pediatr Oncol. 1990;18(4):321-4. doi: 10.1002/mpo.2950180413.

Abstract

To determine the maximum tolerated dose of 5-fluorouracil administered as a 120-hour continuous intravenous infusion to pediatric patients, we performed a phase I study using a starting dosage of 900 mg/m2/day. The maximum tolerated dosage (MTD) was 1,100 mg/m2/day. At this dosage level 40% of courses were complicated by grade 3 mucositis. Three additional patients were treated at the dosage level of 1,000 mg/m2/day after the MTD was determined. We recommend the dosage level of 1,000 mg/m2/day for phase II studies of 5-fluorouracil administered as a 120-hour continuous intravenous infusion to pediatric patients.

Publication types

  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adolescent
  • Alanine Transaminase / blood
  • Alkaline Phosphatase / metabolism
  • Aspartate Aminotransferases / blood
  • Child
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Evaluation
  • Fluorouracil / administration & dosage*
  • Fluorouracil / adverse effects
  • Gastrointestinal Diseases / chemically induced
  • Hematologic Diseases / chemically induced
  • Humans
  • Infusions, Intravenous
  • Neoplasms / drug therapy*
  • Recurrence

Substances

  • Aspartate Aminotransferases
  • Alanine Transaminase
  • Alkaline Phosphatase
  • Fluorouracil