A phase of I trial of 4'-epi-Adriamycin.
4'-epi-adriamycin was administered intravenously on an every-3-week schedule to 34 patients with advanced malignant tumors. Patients were treated at five dosage levels, ranging from 40 mg/m2 to 100 mg/m2. Hematologic toxicity was dose limiting. No cardiac, renal, or hepatic toxicity was observed; there were no drug-related deaths. Partial alopecia developed in all patients receiving a cumulative dose of 200 mg/m2; mild nausea and vomiting occurred in 13 patients. Although major therapeutic responses were not seen in this phase I trial, 2 of 15 patients with objectively measurable disease showed minor responses; 7 patients had stabilization of previously progressing cancer for 3 to 5+ months. A dose of 85 mg/m2 of epi-Adriamycin every 3 weeks seems an appropriate initial dose for phase II studies in patients having a performance status of 70 or higher. A starting dose of 70 mg/m2 is recommended for patients having a lower performance status.
D000505:Alopecia / Q000139:chemically induced; D001853:Bone Marrow / Q000187:drug effects; D004305:Dose-Response Relationship, Drug; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects* / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D009369:Neoplasms / Q000188:drug therapy*; D013921:Thrombocytopenia / Q000139:chemically induced
D004317:Doxorubicin