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: E Rowinsky, L Smith, G Rodriguez, L White, R Drengler, D Von Hoff, N Peacock, C Aylesworth, H Burris, P Ravdin, R Bellet
• Journal: Oncology (Williston Park, N.Y.) (Oncology (Williston Park)) Vol. 11 Issue 6 Suppl 6 Pg. 33-5 (Jun 1997) ISSN: 0890-9091 [Print] United States
• PMID: 9213326 (Publication Type: Clinical Trial, Clinical Trial, Phase I, Journal Article)

Chemical References

• Taxoids
• Docetaxel
• Paclitaxel
• Fluorouracil

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects)
• Docetaxel
• Dose-Response Relationship, Drug
• Fluorouracil (administration & dosage, adverse effects)
• Humans
• Infusions, Intravenous
• Middle Aged
• Neutropenia (chemically induced)
• Paclitaxel (administration & dosage, adverse effects, analogs & derivatives)
• Taxoids