PHASE-I STUDY OF CONTINUOUS VENOUS INFUSION OF FLOXURIDINE (5-FUDR) CHEMOTHERAPY

Abstract

Floxuridine (5-FUDR) was administered by continuous i.v. infusion using an ambulatory portable pump in a phase I study designed to establish the optimal (maximal) daily dose rate to deliver a minimum of 14 days of [antineoplastic] drug therapy. The major determinant of toxicity was dose rather than than cumulative dose. Patients receiving > 0.15 mg/kg day developed dose-limiting diarrhea at 7-14 days (median, 10); patients receiving 0.1-0.125 mg/kg per day were treated for 18-78 days without adverse effects. The recommended daily dose rate for continuous-infusion schedules of 14 days is 0.15 mg/kg per day.