Phase III study of single-dose casopitant in combination with ondansetron and dexamethasone for the prevention of oxaliplatin-induced nausea and vomiting.

9019 Background: Currently, the NK-1 receptor antagonist (NK-1 RA) aprepitant combined with a 5-HT3 receptor antagonist (5-HT3 RA) and dexamethasone (DEX) constitutes the antiemetic standard of care with highly emetogenic chemotherapy (HEC) and with the moderately emetogenic chemotherapy (MEC) agents cyclophosphamide and anthracyclines (AC) when used together. The role of the NK-1 RA’s with MEC other than AC is less clear. Casopitant (GW679769) is an NK-1 RA with demonstrated efficacy when added to ondansetron and DEX in both the HEC and AC-MEC settings. This study was conducted to determine if the addition of a single dose of casopitant to ondansetron and DEX would improve the control of CINV following oxaliplatin-based MEC compared to ondansetron and DEX alone. Methods: Patients (pts) with colorectal cancer undergoing their first cycle of oxaliplatin (85 mg/m2–130 mg/m2) in combination with 5-flourouracil/leucovorin or capecitabine were randomized to receive casopitant (C) 90 mg or placebo (PL) intraven...