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  • Title: A phase I trial of marcellomycin with a weekly dose schedule.
    Author: Joss RA, Kaplan S, Goldhirsch A, Varini M, Brunner KW, Cavalli F.
    Journal: Eur J Cancer Clin Oncol; 1983 Apr; 19(4):455-9. PubMed ID: 6683183.
    Abstract:
    Marcellomycin, a new anthracycline antibiotic, was administered intravenously on a weekly schedule to 22 patients with advanced malignant solid tumors. Patients were treated at 6 dosage levels ranging from 5 to 30 mg/m2 weekly for 4 weeks. Courses were repeated after a 3-week rest period. Hematologic toxicity was dose-limiting but unpredictable. Of 10 patients treated with weekly doses of 27.5 mg/m2, 3 patients exhibited myelosuppression and 2 died in agranulocytosis. Moderate to severe nausea and vomiting occurred in 19 of 22 evaluable patients. Other toxic effects were non-acute and consisted of mild stomatitis, diarrhea, phlebitis and moderate fatigue in 1-3 patients each. In 17 patients evaluable for antitumor activity no partial or complete responses occurred. One patient with advanced breast cancer showed a mixed response. Marcellomycin given on a weekly dose schedule has unpredictable and erratic hematologic toxicity. The maximally tolerated dose appears to be between 27.5 and 30 mg/m2 weekly. However, no firm recommendations can be given for a dose level that results in tolerable, predictable and reversible toxicity.
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