Phase I study of idarubicin administered orally on a daily x 3 schedule.
Twenty-one adult patients with refractory solid tumors were treated on a phase I study of idarubicin (4-demethoxydaunorubicin) administered daily for 3 days every 3 weeks. Nineteen of the patients had received previous chemotherapy (including 13 with prior anthracyclines), and 12 had received prior radiotherapy. Idarubicin dose levels of 10, 15, 17.5, 20, and 25 mg/m2 were explored. Hematological toxicity was dose-related. Other toxicity was acceptable. Only one patient (treated with an idarubicin dose of 17.5 mg/m2/day) developed neutropenic fever, from which he recovered. Further dose escalations beyond 25 mg/m2 were not carried out because of the increasing length of time required for recovery from granulocytopenia at higher doses. No patient experienced a major response, but minor responses were seen in 3 patients with carcinomas of the colon, breast, and kidney respectively. Further phase II studies of oral idarubicin at a starting dose of 20-25 mg/m2 daily times 3 days in patients with good bone marrow reserves are recommended. Because of the degree of neutropenia expected, patients would have to be observed carefully.
Stewart
D J
DJ
Ontario Cancer Treatment and Research Foundation, Ottawa Regional Cancer Centre.
Verma
S
S
Maroun
J A
JA
Robillard
L
L
Perrault
D J
DJ
Young
V
V
Gupta
S
S
Fontaine
B
B
D000284:Administration, Oral; D000328:Adult; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage / Q000627:therapeutic use* / Q000633:toxicity; D008297:Male; D009369:Neoplasms / Q000188:drug therapy
D015255:Idarubicin