Stratified, Randomized, Double-Blind Comparison of Intravenous Ondansetron Administered as a Multiple-Dose Regimen Versus Two Single-Dose Regimens in the Prevention of Cisplatin-Induced Nausea and Vomiting

Purpose: This study compares the efficacy and safety of two single-dose regimens with the approved three-dose regimen of ondansetron in the prevention of cispla-tin-induced emesis. Patients and Methods: This multicenter study was a stratified, randomized, double-blind, and parallel group design. Chemotherapy-naive inpatients were random-ized to receive intravenous (IV) ondansetron (Zofran; Glaxo Inc, Research Triangle Park, NC) 0.15 mg/kg times three doses, every 4 hours or a single 8-mg or 32-mg dose followed by two saline doses that began 30 minutes before cisplatin administration. Cisplatin (high-dose-a 100 mg/m2 or medium-dose 50 to 70 mg/m 2) was given as a single infusion (s 3 hours). Patients were monitored for emetic episodes, adverse events, and laboratory safet