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Phase I studies on chlorozotocin.

D Hoth, P Woolley, D Green

    Clinical Pharmacology and Therapeutics
    |June 1, 1978
    PubMed
    Summary
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    Chlorozotocin, a novel nitrosourea, showed manageable toxicity in phase I trials. The recommended dose for further study is 120 mg/m2 every 6 weeks, with some patients showing therapeutic activity.

    Area of Science:

    • Oncology
    • Pharmacology
    • Clinical Trials

    Background:

    • Chlorozotocin is a novel, water-soluble chloroethylnitrosourea.
    • Phase I trials are crucial for evaluating new cancer therapeutics.

    Purpose of the Study:

    • To define the pharmacologic effects and safety profile of chlorozotocin in humans.
    • To determine the maximum tolerated dose and recommended dose for phase II studies.

    Main Methods:

    • A phase I clinical trial involving 43 patients receiving single intravenous doses of chlorozotocin.
    • Dose escalation from 5 to 175 mg/m2 every 6 weeks.
    • Pharmacokinetic analysis and toxicity monitoring.

    Main Results:

    • Thrombocytopenia was the primary dose-limiting toxicity, occurring at doses above 120 mg/m2.

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  • Mild, reversible elevations in hepatic transaminases were observed.
  • Rapid triphasic plasma clearance and significant renal excretion of the drug were noted.
  • Objective signs of therapeutic activity were seen in 5 patients, including 3 with melanoma.

    • Conclusions:

    • The recommended dose for phase II investigation of chlorozotocin is 120 mg/m2 every 6 weeks.
    • Chlorozotocin demonstrates a manageable safety profile and potential therapeutic activity in certain cancers.