title: 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.
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.
authors.affiliation: Department of Pediatrics, Roswell Park Cancer Institute and School of Medicine, State University of New York, Buffalo.
authors.forename: D M
authors.initials: DM
authors.lastname: Green
authors.forename: J P
authors.initials: JP
authors.lastname: Krischer
authors.forename: B
authors.initials: B
authors.lastname: Bell
authors.forename: M L
authors.initials: ML
authors.lastname: Brecher
authors.forename: B
authors.initials: B
authors.lastname: Cushing
authors.forename: V M
authors.initials: VM
authors.lastname: Whitehead
mesh_terms: D000293:Adolescent; D000410:Alanine Transaminase / Q000097:blood; D000469:Alkaline Phosphatase / Q000378:metabolism; D001219:Aspartate Aminotransferases / Q000097:blood; D002648:Child; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005472:Fluorouracil / Q000008:administration & dosage* / Q000009:adverse effects; D005767:Gastrointestinal Diseases / Q000139:chemically induced; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D009369:Neoplasms / Q000188:drug therapy*; D012008:Recurrence
chemical_list: D001219:Aspartate Aminotransferases; D000410:Alanine Transaminase; D000469:Alkaline Phosphatase; D005472:Fluorouracil