Phase II trial of a single intravenous dose of ondansetron in patients receiving cisplatin > or = 100 mg/m2.
Ondansteron, a serotonin antagonist antiemetic, controls emesis caused by cisplatin when given as multiple 0.15 mg/kg dosages in a variety of administration schedules. This trial evaluated a single 0.45 mg/kg i.v. dose of ondansetron in 21 cancer patients receiving cisplatin at doses > or = 100 mg/m2 as initial chemotherapy. Twenty-five percent of patients had no emetic episodes (95% confidence interval: 9-49%), and 45% had two or fewer emetic episodes (95% confidence interval: 23-69%). No significant adverse effects were seen. In prior trials at this institution in similarly treated patients, ondansetron given in three divided doses yielded a 42% no emesis rate. In this trial a single i.v. 0.45 mg/kg dose of ondansetron prevented emesis in 25% of patients receiving initial cisplatin > or = 100 mg/m2. For this dose of cisplatin and ondansetron, the observed emesis complete control rate was lower than that previously seen using multiple dose schedules.
Kris
M G
MG
Department of Medicine, Memorial Sloan-Kettering Cancer Center, Cornell University Medical College, New York, New York 10021.
Clark
R A
RA
Tyson
L B
LB
Hahne
W F
WF
Pisters
K M
KM
Gralla
R J
RJ
D000328:Adult; D000368:Aged; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced* / Q000517:prevention & control; D017294:Ondansetron / Q000008:administration & dosage / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced* / Q000517:prevention & control
D017294:Ondansetron; D002945:Cisplatin