[Phase I study of an oral administration of VP 16-213].
A phase I study of VP-16-213 oral capsule was performed in 25 patients with various malignant tumors refractory to standard treatments. Doses were escalated from 50 mg/d to 300 mg/d by a 5-day administration. Leukopenia was dose-related and nadirs at 200 mg/d, 250 mg/d and 300 mg/d were 2,000, 1,600 and 700/cmm respectively, reaching in about 2 weeks and approximately one week was required for recovery. Thrombocytopenia was also dose-related but generally less frequent and milder than leukopenia. Gastrointestinal toxicities such as anorexia, nausea and vomiting occurred in about 20% of patients but well tolerated; alopecia was observed in 40%. The result indicated that an optimal dose of oral VP-16-213 for phase II study was daily 200 mg/d (approximately 130 mg/m2) for 5 consecutive administration in 3-week intervals.
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002214:Capsules; D004334:Drug Administration Schedule; D004341:Drug Evaluation; D005047:Etoposide / Q000008:administration & dosage* / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy; D008223:Lymphoma / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011034:Podophyllotoxin / Q000031:analogs & derivatives*
D002214:Capsules; D005047:Etoposide; D011034:Podophyllotoxin