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[Phase I study of paclitaxel]

N Horikoshi1, K Inoue, K Aiba

  • 1Dept. of Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research.

Gan to Kagaku Ryoho. Cancer & Chemotherapy
|October 1, 1994
PubMed
Summary

This phase I study evaluated paclitaxel (Taxol) in cancer patients. The recommended dose for phase II trials is 150 mg/m2 every 3 weeks, with leukopenia being the dose-limiting toxicity.

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Area of Science:

  • Oncology
  • Pharmacology

Background:

  • Paclitaxel is a novel antimicrotubule agent.
  • It enhances tubulin polymerization and microtubule stability.

Purpose of the Study:

  • To determine the maximum tolerated dose (MTD) of paclitaxel.
  • To evaluate the safety and pharmacokinetics of paclitaxel administered as a 24-hour infusion.
  • To identify a recommended dose for phase II studies.

Main Methods:

  • Phase I clinical trial involving 12 patients.
  • Paclitaxel administered as a 24-hour infusion at doses of 50, 100, 150, and 200 mg/m2.
  • Premedication with dexamethasone, diphenhydramine, and ranitidine.
  • Monitoring for toxicities, including hypersensitivity reactions (HSRs) and hematological effects.

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  • Pharmacokinetic analysis of plasma concentration, half-life, and urinary excretion.

    • Main Results:

    • Leukopenia (granulocytopenia) with Grade 4 infection was the dose-limiting toxicity.
    • The maximum tolerated dose (MTD) was determined to be 200 mg/m2.
    • Non-hematological toxicities included peripheral neuropathy, myalgia, alopecia, and elevated transaminases and alkaline phosphatase.
    • Severe HSRs were not observed.
    • Paclitaxel plasma half-life ranged from 10.0 to 24.9 hours.
    • Urinary excretion within 72 hours was 7.28–11.34% of the dosage.
    • Two partial responses were observed in breast cancer patients at 200 mg/m2.

    Conclusions:

    • The recommended dose of paclitaxel for phase II studies, administered as a 24-hour infusion, is 150 mg/m2 every 3 weeks.
    • Paclitaxel demonstrates manageable toxicity with appropriate premedication.
    • Further investigation in phase II studies is warranted.