A Phase I Clinical Trial of Aclacinomycin A Administered on a Five‐Consecutive‐Day Schedule

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Abstract
In this Phase I study, the new anthracycline aclacinomycin A was given to 22 advanced cancer patients on a schedule of daily intravenous administration for five days repeated every four weeks. The limiting toxicity was myelosuppression, which was severe at a dose of 30 mg/m2 per day for five days. Platelet nadirs were more marked than those of white cells and occurred at about day 11 after the first drug dose, while maximum leukopenia occurred at day 21. Some patients had moderate nausea and vomiting. No hepatic or renal toxicity was observed, and alopecia was minimal. Cardiac function was monitored prospectively, using radionuclide left ventricular ejection fractions and serial ECGs. One patient developed transient atrial fibrillation; and one other, who had previously received 380 mg/m2 doxorubicin, developed congestive heart failure. Otherwise there was no evidence of cardiac toxicity. No tumor regressions were seen. We conclude that 150 mg/m2 given in five daily 30 mg/m2 fractions is a maximum tolerated dose of aclacinomycin A. This is higher than the reported MTD of 120 mg/m2 for single bolus injection. We recommend a Phase II starting dose of 25 mg/m2 per day for good‐risk patients and 20 mg/m2 per day for poor‐risk patients when the drug is given on this schedule.

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