Phase I study of paclitaxel

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

Research output: Contribution to journalArticle

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/m 2 . 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/m 2 . 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/m 2 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/m 2 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
Externally publishedYes

Fingerprint

Paclitaxel
Hypersensitivity
Diphenhydramine
Agranulocytosis
Ranitidine
Maximum Tolerated Dose
Premedication
Myalgia
Alopecia
Leukopenia
Peripheral Nervous System Diseases
Tubulin
Transaminases
Microtubules
Polymerization
Dexamethasone
Alkaline Phosphatase
Half-Life
Urine
Breast Neoplasms

All Science Journal Classification (ASJC) codes

  • Oncology
  • Cancer Research

Cite this

Horikoshi, N., Inoue, K., Aiba, K., Mukaiyama, T., Ogihara, A., Sumida, T., ... Ogawa, M. (1994). Phase I study of paclitaxel. Japanese Journal of Cancer and Chemotherapy, 21(14), 2407-2414.
Horikoshi, N. ; Inoue, K. ; Aiba, K. ; Mukaiyama, T. ; Ogihara, A. ; Sumida, T. ; Akatsuka, Yoshiki ; Bessho, A. ; Inamoto, Y. ; Uchida, T. ; Koga, H. ; Ogawa, M. / Phase I study of paclitaxel. In: Japanese Journal of Cancer and Chemotherapy. 1994 ; Vol. 21, No. 14. pp. 2407-2414.
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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, vol. 21, no. 14, pp. 2407-2414.

Phase I study of paclitaxel. / Horikoshi, N.; Inoue, K.; Aiba, K.; Mukaiyama, T.; Ogihara, A.; Sumida, T.; Akatsuka, Yoshiki; Bessho, A.; Inamoto, Y.; Uchida, T.; Koga, H.; Ogawa, M.

In: Japanese Journal of Cancer and Chemotherapy, Vol. 21, No. 14, 15.11.1994, p. 2407-2414.

Research output: Contribution to journalArticle

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AU - Sumida, T.

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Horikoshi N, Inoue K, Aiba K, Mukaiyama T, Ogihara A, Sumida T et al. Phase I study of paclitaxel. Japanese Journal of Cancer and Chemotherapy. 1994 Nov 15;21(14):2407-2414.