A phase I study of suramin with once- or twice-monthly dosing in patients with advanced cancer

Christopher W. Ryan, Everett E. Vokes, Nicholas J. Vogelzang, Linda Janisch, Ken Kobayashi, Mark J. Ratain

    Research output: Contribution to journalArticle

    7 Scopus citations

    Abstract

    Purpose: The optimal schedule of administration of suramin has not been well defined. The purpose of this study was to determine the maximum tolerated dose and toxicities of suramin when administered using a fixed dosing scheme on a once- or twice-monthly schedule. Methods: A total of 40 patients were treated on this phase I dose-escalation study employing a once-monthly (day 1 of each 28-day cycle) and a twice-monthly (days 1 and 8 of each 28-day cycle) schedule. Results: The most common dose-limiting events included fatigue, neuropathy, and anorexia. We identified the 1440 mg/m2 dose level to be the maximal tolerated dose for both schedules, with 83% of patients developing dose-limiting toxicity (DLT) on the twice-monthly schedule, and 67% developing DLT on the monthly schedule. At the 1200 mg/m2 dose level, only 25% developed DLT on the twice-monthly schedule and 33% developed DLT on the monthly schedule. Trough suramin levels gradually increased with higher dose levels but fell well below the putative toxic concentration of 350 μg/ml. Conclusion: Suramin can be safely administered using a monthly schedule without using plasma concentrations to guide dosing.

    Original languageEnglish (US)
    Pages (from-to)1-5
    Number of pages5
    JournalCancer Chemotherapy and Pharmacology
    Volume50
    Issue number1
    DOIs
    StatePublished - Jul 18 2002

    Keywords

    • Adaptive control
    • Clinical trial
    • Phase I
    • Suramin

    ASJC Scopus subject areas

    • Oncology
    • Toxicology
    • Pharmacology
    • Cancer Research
    • Pharmacology (medical)

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