A phase I study of docetaxel, cisplatin, 5-fluorouracil and leucovorin

Mary F. Mulcahy, Patrick Loehrer, Neal J. Meropol, Alfred W. Rademaker, Al B. Benson

Research output: Contribution to journalArticle

Abstract

Objectives: Cisplatin, 5-fluorouracil (5-FU) and docetaxel are active agents in the treatment of upper gastrointestinal malignancies. This phase I study was undertaken to determine the maximally tolerated dose and dose-limiting toxicities of a combination of these drugs given in an ambulatory setting using a bolus schedule of 5-FU. Methods: Twenty patients with gastrointestinal malignancies were treated with docetaxel on day 1, cisplatin on day 2 and bolus 5-FU with leucovorin each day for 5 days, without prophylactic antibiotics or colony-stimulating factors. The cycle was repeated at 21-day intervals. A dose-escalating phase I design was used. Results: There were two treatment-related deaths as a result of neutropenia and sepsis. The maximally tolerated dose was docetaxel at 60 mg/m2 on day 1, cisplatin at 75 mg/m2 on day 2 and 5-FU at 200 mg/m2 with leucovorin at 20 mg/m2 daily from day 1 to day 5. At this dose, neutropenia was occurring in 4 of 6 patients treated. There were three partial responses, 1 patient with esophagogastric cancer and 2 with gastric cancer. Conclusions: This regimen demonstrates efficacy in upper gastrointestinal malignancies. Strategies to improve the tolerance of these agents in combination should be pursued.

Original languageEnglish
Pages (from-to)479-484
Number of pages6
JournalOncology
Volume68
Issue number4-6
DOIs
StatePublished - Aug 2005

Fingerprint

docetaxel
Leucovorin
Fluorouracil
Cisplatin
Maximum Tolerated Dose
Neutropenia
Neoplasms
Colony-Stimulating Factors
Drug Combinations
Stomach Neoplasms
Sepsis
Appointments and Schedules
Anti-Bacterial Agents
Therapeutics

Keywords

  • Docetaxel
  • Gastric cancer
  • Phase I trials

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Mulcahy, M. F., Loehrer, P., Meropol, N. J., Rademaker, A. W., & Benson, A. B. (2005). A phase I study of docetaxel, cisplatin, 5-fluorouracil and leucovorin. Oncology, 68(4-6), 479-484. https://doi.org/10.1159/000086991

A phase I study of docetaxel, cisplatin, 5-fluorouracil and leucovorin. / Mulcahy, Mary F.; Loehrer, Patrick; Meropol, Neal J.; Rademaker, Alfred W.; Benson, Al B.

In: Oncology, Vol. 68, No. 4-6, 08.2005, p. 479-484.

Research output: Contribution to journalArticle

Mulcahy, MF, Loehrer, P, Meropol, NJ, Rademaker, AW & Benson, AB 2005, 'A phase I study of docetaxel, cisplatin, 5-fluorouracil and leucovorin', Oncology, vol. 68, no. 4-6, pp. 479-484. https://doi.org/10.1159/000086991
Mulcahy, Mary F. ; Loehrer, Patrick ; Meropol, Neal J. ; Rademaker, Alfred W. ; Benson, Al B. / A phase I study of docetaxel, cisplatin, 5-fluorouracil and leucovorin. In: Oncology. 2005 ; Vol. 68, No. 4-6. pp. 479-484.
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