A double-blind randomized phase II study of 10 versus 5 mg olanzapine for emesis induced by highly emetogenic chemotherapy with cisplatin.

10111Background: The aim of this phase II study was to evaluate the efficacy and safety of　two doses (10 and 5 mg) of olanzapine (OLZ) in combination with standard　antiemetic treatment (aprepitant [APR], palonosetron [PALO], and　dexamethasone [DEX]) to determine the better dose of OLZ as a test arm in a　subsequent placebo controlled phase III study for patients receiving highly emetogenic chemotherapy (HEC). Methods: A multi-institutional, double-blind, randomized phase II, dose-finding study of OLZ was performed in patients with a malignant solid tumor who were receiving HEC with cisplatin (CDDP, ≥ 50 mg/m2). Patients were randomly assigned either OLZ 10 or 5 mg orally after supper on days 1–4, combined with APR (125 mg p.o. on day 1, 80 mg p.o. on days 2–3), PALO (0.75 mg i.v. on day 1) and DEX (9.9 mg i.v. on day 1 and 6.6 mg i.v. on days 2–4). The primary endpoint was a complete response (CR), defined as no emetic episodes and rescue medications used in the delayed phase (24 to 120 h). At least 72 pat...