A double-blind randomized Phase II study of olanzapine 10 mg versus 5 mg for emesis induced by highly emetogenic chemotherapy.
A randomized Phase II dose-finding trial comparing olanzapine 10 mg with olanzapine 5 mg for patients receiving highly emetogenic chemotherapy with cisplatin was started in June 2014. The purpose of the trial is to evaluate the efficacy and safety of the two olanzapine doses and to determine which is more promising as a test arm for comparison with the current standard antiemetic care (a combination of aprepitant, a 5-HT3 receptor antagonist and dexamethasone) in a subsequent Phase III trial. Patients receiving cisplatin-containing regimens will be randomized to the olanzapine 10 or 5 mg arm. A total of 150 patients will be accumulated from nine institutions over 2 years. The primary endpoint is complete response defined as no emetic episodes and no use of rescue medications in the delayed (24-120 h) phase. This trial has been registered at the UMIN Clinical Trials Registry as UMIN000014214.
Clinical Research Center, Chiba University Hospital, Chiba.
Kengo
K
Nagashima
National Cancer Center Hospital, Tokyo.
Satoru
S
Iwasa
National Cancer Center Hospital, Tokyo.
Takako
T
Yanai
National Cancer Center Hospital, Tokyo.
Hironobu
H
Hashimoto
Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Kenichi
K
Suzuki
Cancer Institute Hospital of Japanese Foundation for Cancer Research, Tokyo, Japan.
Fumiyoshi
F
Ohyanagi
National Cancer Center Hospital, Tokyo.
Yasuhiro
Y
Shimada
National Cancer Center Hospital, Tokyo nbryamam@ncc.go.jp.
Noboru
N
Yamamoto
D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D000077608:Aprepitant; D001569:Benzodiazepines / Q000008:administration & dosage*; D002945:Cisplatin / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004639:Emetics / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage; D009325:Nausea / Q000139:chemically induced* / Q000188:drug therapy*; D000077152:Olanzapine; D018579:Patient Selection; D012107:Research Design; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced* / Q000517:prevention & control*
D000932:Antiemetics; D000970:Antineoplastic Agents; D004639:Emetics; D009025:Morpholines; D001569:Benzodiazepines; D000077608:Aprepitant; D003907:Dexamethasone; D000077152:Olanzapine; D002945:Cisplatin
highly emetogenic chemotherapy; nausea; olanzapine; vomiting