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Phase I study with 4'-deoxydoxorubicin.

L Ferrari, A Rossi, C Brambilla

    Investigational New Drugs
    |January 1, 1984
    PubMed
    Summary
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    4'-Deoxydoxorubicin (dxDx), a novel doxorubicin analog, showed therapeutic activity in advanced cancers. Myelosuppression was the main toxicity, but hepatic and renal effects were absent, suggesting a manageable safety profile for this chemotherapy agent.

    Area of Science:

    • Oncology
    • Pharmacology
    • Clinical Trials

    Background:

    • Advanced malignant neoplasms present significant treatment challenges.
    • Doxorubicin analogues are explored for improved efficacy and safety profiles.
    • 4'-Deoxydoxorubicin (dxDx) is a novel analogue investigated for its therapeutic potential.

    Purpose of the Study:

    • To evaluate the safety and efficacy of 4'-Deoxydoxorubicin (dxDx) in patients with advanced cancers.
    • To determine the dose-limiting toxicities and maximum tolerated dose (MTD) of dxDx.
    • To assess the therapeutic activity of dxDx across various advanced malignancies.

    Main Methods:

    • Intravenous administration of dxDx on a 3-week schedule to 73 patients with advanced cancers.
    • Dose escalation study with eight dose levels ranging from 10 to 45 mg/m2.

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  • Evaluation of therapeutic response and toxicity, including myelosuppression, gastrointestinal effects, and cardiovascular parameters.

    • Main Results:

    • Therapeutic activity observed with dxDx doses from 25 to 45 mg/m2, with partial responses in pancreatic, colon, anal, breast cancers, and non-Hodgkin's lymphoma.
    • Dose-limiting toxicity was myelosuppression (leukopenia); vomiting and mild hair loss were common.
    • No significant hepatic or renal toxicity; transient ECG changes and rare decreases in left ventricular ejection fraction were noted at higher cumulative doses.

    Conclusions:

    • 4'-Deoxydoxorubicin (dxDx) demonstrates therapeutic activity in advanced malignancies with a manageable toxicity profile.
    • The maximum tolerated dose of dxDx was determined to be between 40 and 45 mg/m2.
    • A Phase II trial is ongoing to further evaluate dxDx at a dose of 35 mg/m2 every 3 weeks.