Phase i study of bisantrene in acute nonlymphoblastic leukemia
Marty, M.; Ferme, C.; Gisselbrecht, C.; Guy, H.; Clark, M.J.; Bancillon, A.; Boiron, M.
Cancer Treatment Reports 69(6): 703-705
1985
ISSN/ISBN: 0361-5960 PMID: 4016773 Document Number: 252984
A phase I study of bisantrene using a daily injection for 5 days was undertaken in adult patients with relapsing acute nonlymphoblastic leukemia. Seventeen patients received 27 courses, with daily doses ranging from 75 to 250 mg/m2. Although gastrointestinal toxicity and alopecia were rare, hematological toxicity occurred in 85% of the patients. There was cholestasis unrelated to infectious events in 27% of the courses, as well as reversible renal failure in eight of 27 evaluable courses. Responses (complete + partial) were obtained in 35% +/- 10% of the patients. The recommended dose for phase II study is 200 mg/m2/day X 7.