PHASE-I STUDY OF ECHINOMYCIN ADMINISTERED ON AN INTERMITTENT BOLUS SCHEDULE

  • 1 December 1985
    • journal article
    • research article
    • Vol. 69  (12) , 1365-1368
Abstract
We have conducted a phase I study of the cyclic peptide echinomycin (Quinomycin A) on a schedule of administration of once every 4 weeks. Ten dose levels between 20 and 1800 .mu.g/m2 were studied. Acute gastrointestinal toxicity was severe and dose-limiting in several patients at doses of 1800 .mu.gm2. Thrombocytopenia was erratic, but generally increased with drug doses. Platelet count nadirs occurred 5-10 days after administration. Hepatic toxicity was reflected in transient elevations of serum transaminases without hyperbilirubinemia. Three patients experienced apparent anaphylactic reactions to doses of 1500 .mu.g/m2. The maximum tolerated single dose of echinomycin was 1800 .mu.g/m2. A starting phase II dose of 1500 .mu.g/m2 is recommended.