PHASE-I TRIAL OF A NEW FORM OF AN ORAL-ADMINISTRATION OF VP-16-213

  • 1 January 1979
    • journal article
    • research article
    • Vol. 63  (3) , 485-487
Abstract
A new oral form of VP-16-213 [4''-demethylepipodophyllotoxin-.beta.-D-ethylidene] consisting of a hydrophilic soft gelatin capsule containing a VP-16-213 solution was tested for toxicity in 26 cancer patients. The drug was administered at 4 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. 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.