Phase I trial of a new form of an oral administration of VP-16-213.
A new oral form of VP-16-213 consisting of a hydrophilic soft gelatin capsule containing a VP-16-213 solution was tested for toxicity in 26 patients. The drug was administered at four different dose levels, 350, 500, 650, and 750 mg/m2, in 5-day courses every 21-28 days. A dose-dependent effect was observed with regard to hematologic toxicity and alopecia. It is concluded that the drinking ampules of VP-16-213 can be replaced with the new oral capsules with a recommended initial dose of 100-130 mg/m2 given in 5-day courses every 21-28 days.
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002214:Capsules; D002986:Clinical Trials as Topic; D004341:Drug Evaluation; D005047:Etoposide / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006402:Hematologic Diseases / Q000139:chemically induced; D006801:Humans; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000188:drug therapy*; D011034:Podophyllotoxin / Q000031:analogs & derivatives*
D002214:Capsules; D005047:Etoposide; D011034:Podophyllotoxin