title: Docetaxel in combination with fluorouracil: study design and preliminary results.
abstract: The relatively recent introduction of a new class of chemotherapeutic agents--the taxoids--has raised hope of improved survival for patients with advanced or metastatic cancer. Following encouraging preclinical results of taxoid combinations, this phase I, nonrandomized trial was designed to evaluate a 1-hour intravenous infusion of docetaxel (Taxotere) on day 1 combined with fluorouracil (5-FU) as a daily intravenous bolus for 5 consecutive days. To date, 27 patients with advanced solid neoplasms have received 86 courses of docetaxel/5-FU at the following dose levels: 25/100, 35/150, 50/200, 60/200, and 60/300 mg/m2. Preliminary results showed no unexpected toxicities, and the principal toxicity was neutropenia of short duration. A treatment regimen of 60 mg/m2 docetaxel on day 1 and 300 mg/m2 of 5-FU given for 5 days, with a single course length of 28 days, is projected as the maximum tolerated dose.
authors.affiliation: Cancer Therapy and Research Center, Institute for Drug Development, San Antonio, Texas, USA.
authors.forename: E
authors.initials: E
authors.lastname: Rowinsky
authors.forename: L
authors.initials: L
authors.lastname: Smith
authors.forename: G
authors.initials: G
authors.lastname: Rodriguez
authors.forename: L
authors.initials: L
authors.lastname: White
authors.forename: R
authors.initials: R
authors.lastname: Drengler
authors.forename: D
authors.initials: D
authors.lastname: Von Hoff
authors.forename: N
authors.initials: N
authors.lastname: Peacock
authors.forename: C
authors.initials: C
authors.lastname: Aylesworth
authors.forename: H
authors.initials: H
authors.lastname: Burris
authors.forename: P
authors.initials: P
authors.lastname: Ravdin
authors.forename: R
authors.initials: R
authors.lastname: Bellet
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D043823:Taxoids
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel; D005472:Fluorouracil