[A phase I trial of idarubicin by oral administration].
A phase I trial of a new anthracycline derivative, idarubicin, was conducted in 16 patients with various advanced solid tumors. Doses administered were 20, 30 and 40 mg/m2 with single oral doses. Dose-limiting factors were both leukopenia and thrombocytopenia reaching a nadir about 2 weeks after the start of treatment and requiring 7 to 10 days for recovery. Other toxicities were anorexia, nausea and vomiting, but alopecia did not occur. The maximum tolerated dose was judged to be 40 mg/m2 and the recommended dose for phase II trials was determined to be 30-35 mg/m2.
Ogawa
M
M
Kimura
K
K
Taguchi
T
T
Wakui
A
A
Hattori
M
M
Shimoyama
T
T
Fujita
H
H
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000903:Antibiotics, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D003630:Daunorubicin / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D004341:Drug Evaluation; D005260:Female; D005770:Gastrointestinal Neoplasms / Q000188:drug therapy*; D006801:Humans; D015255:Idarubicin; D008297:Male; D008875:Middle Aged; D014594:Uterine Neoplasms / Q000188:drug therapy*
D000903:Antibiotics, Antineoplastic; D015255:Idarubicin; D003630:Daunorubicin