Phase I trial of ICRF-187 by 48-hour continuous infusion

J. M. Koeller, R. H. Earhart, H. L. Davis

    Research output: Contribution to journalArticle

    18 Scopus citations

    Abstract

    ICRF-187 is the D-enantiomer of the racemic antitumor agent ICRF-159 and was selected for clinical trials on the basis of aqueous solubility suitable for iv administration. Eighteen patients with refractory advanced solid tumors received ICRF-187 by a 48-hour continuous iv infusion in 5% Dextrose in Water, USP. The total dose ranged from 200 to 1000 mg/m2/48 hours. Courses were repeated at 22-28 day intervals. The major toxic effect was reversible granulocytopenia, with the nadir on Day 12 and the recovery by Day 22. At a dose of 1000 mg/m2/48 hours, the median nadir total wbc count was 1700/mm3 (range, 1300-2600), and the median nadir granulocyte count was 597/mm3 (range, 270-1300). Platelet count nadirs of < 100,000/mm3 occurred in only three of 16 courses at this level. Granulocyte toxicity was not cumulative and was less severe in repeated courses (median nadir, 1000/mm3 in courses two and three). Mild nausea, malaise, and three instances of alopecia were the only nonhematologic toxic effects encountered. Compared to other schedules, a continuous 48-hour infusion of ICRF-187 seems to have greater toxic effects for a given total dose, and this may predict greater biologic effect. A starting dose of 1000 mg/m2 by a 48-hour continuous infusion is recommended for phase II trials.

    Original languageEnglish (US)
    Pages (from-to)459-463
    Number of pages5
    JournalCancer Treatment Reports
    Volume65
    Issue number5-6
    StatePublished - Jan 1 1981

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research

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  • Cite this

    Koeller, J. M., Earhart, R. H., & Davis, H. L. (1981). Phase I trial of ICRF-187 by 48-hour continuous infusion. Cancer Treatment Reports, 65(5-6), 459-463.