Phase I study of paclitaxel

N. Horikoshi, K. Inoue, K. Aiba, T. Mukaiyama, A. Ogihara, T. Sumida, Y. Akatsuka, A. Bessho, Y. Inamoto, T. Uchida, H. Koga, M. Ogawa

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8 Citations (Scopus)

Abstract

Paclitaxel, a novel antimicrotubule agent that enhances tubulin polymerization and microtubule stability, was administered as a 24-hour infusion in a phase I study. Twelve patients received 32 courses at 50, 100, 150, and 200 mg/m2. A premedication regimen of dexamethasone, diphenhydramine, and ranitidine was used to prevent the acute hypersensitivity reactions (HSRs). The dose-limiting factor was leukopenia (granulocytopenia) associated with Grade 4 infection. The maximum tolerated dose was 200 mg/m2. Other non-hematological effects included peripheral neuropathy, myalgia, alopecia, and elevations of transaminase and alkaline phosphatase. Severe HSRs were not observed. The paclitaxel plasma concentration declined with a half-life of 10.0 to 24.9 hours. Excretion into urine within 72 hours was in the range of 7.28 to 11.34% of paclitaxel dosage. Two patients with breast cancer at the 200 mg/m2 dose level had partial responses. The recommended dose of paclitaxel for phase II study, when administered as a 24-hour infusion, is considered to be 150 mg/m2 every 3 weeks.

Original languageEnglish
Pages (from-to)2407-2414
Number of pages8
JournalJapanese Journal of Cancer and Chemotherapy
Volume21
Issue number14
Publication statusPublished - 15-11-1994

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

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    Horikoshi, N., Inoue, K., Aiba, K., Mukaiyama, T., Ogihara, A., Sumida, T., Akatsuka, Y., Bessho, A., Inamoto, Y., Uchida, T., Koga, H., & Ogawa, M. (1994). Phase I study of paclitaxel. Japanese Journal of Cancer and Chemotherapy, 21(14), 2407-2414.