CLINICAL PHASE-1 STUDY OF ACLACINOMYCIN-A BY EVALUATION OF AN INTERMITTENT INTRAVENOUS ADMINISTRATION SCHEDULE

  • 1 January 1981
    • journal article
    • research article
    • Vol. 41  (6) , 2417-2420
Abstract
Aclacinomycin A (ACM) is an anthracycline antibiotic recently introduced into clincal trials because of its reduced cardiac toxicity in animal models relative to adriamycin and daunomycin. This Phase I study of ACM was conducted to determine a dose suitable for i.v. administration on an every-3-wk schedule. Twenty-five adult patients with solid tumors were treated with doses of ACM ranging from 60-120 mg/m2 i.v. every 3-4 wk. Myelosuppression was the dose-limiting toxicity, but the degree and timing of blood count depression were variable at each dose level. Nausea and vomiting were seen at myelosuppressive doses; mucositis was rare. Alopecia was seen in approximately 1/3 of the patients. There was no acute cardiac toxicity, but cumulative cardiac injury could not be evaluated in this trial. There were no major objective responses in 3 patients who had measurable disease. The recommended doses of ACM for Phase II studies are 100 mg/m for good-risk patients and 80 mg/m2 for patients who are heavily pretreated or who have a poor performance status.

This publication has 1 reference indexed in Scilit: