Pilot Study on the Efficacy of an Ondansetron Versus Palonosetron-containing Antiemetic Regimen Prior to Highly Emetogenic Chemotherapy(HEC).
I. The goal of this study is to evaluate the overall complete response rate (CR, no emesis
and no use of rescue medication from 0 to 120 hours after chemotherapy) of two different
antiemetic regimens (palonosetron + aprepitant + dexamethasone and ondansetron + aprepitant
+ dexamethasone) for patients undergoing the first cycle of highly emetogenic chemotherapy
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive palonosetron hydrochloride intravenously (IV) 30 minutes prior to
chemotherapy on day 1, aprepitant orally (PO) 60 minutes prior to chemotherapy on days 1-3,
and dexamethasone PO 30 minutes prior to chemotherapy on days 1-4.
ARM II: Patients receive ondansetron PO 30 minutes prior to chemotherapy on day 1 and
aprepitant and dexamethasone as in Arm I.
After completion of study treatment, patients are followed up for 7 days.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Overall CR after the first course of HEC, defined as no emesis and no use of rescue medication
We will use exact binomial methods to estimate proportions and their associated 95% confidence intervals.
Up to 120 hours after completion of chemotherapy
Ohio State University
United States: Institutional Review Board
|Ohio State University Medical Center||Columbus, Ohio 43210|