A Randomized Open Label Phase II Trial of Aprepitant (Emend) in Combination With Ondansetron Compared to Standard 5HT3 Serotonin Antagonist (Ondansetron) in the Prevention of Acute and Delayed Chemotherapy Induced Nausea and Vomiting (CINV) in Glioma Patients Receiving a Temozolomide Based Regimen
One hundred and thirty-six (136) malignant glioma patients receiving temozolomide will be
accrued in this open labeled phase II randomized single institution trial of Aprepitant in
combination with Ondansetron vs. Ondansetron alone for the prevention of acute and delayed
CINV. Sixty-eight (68) patients will be randomized to each arm of the study. Patient
randomization will be stratified by grade (I/II vs. III/IV) and the number of prior
progressions (0/1 versus 2). Within each of the 4 strata defined by these factors, a
permuted block randomization scheme will be used to assign patients to receive either
Ondansetron with or without Aprepitant.
Though the study is comparative, the goal of the study is to determine whether Aprepitant is
worthy of further investigation in this setting, and not to make definitive statements about
the comparative effectiveness Ondansetron treatment with or without Aprepitant.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Proportion of patients achieving an acute and delayed complete response (CR)
Assessed from the beginning of study day 1, CR is defined for acute CINV as no emetic episode and no use of rescue anti-nausea medication during the first 24 hours following chemotherapy administration. CR is defined for delayed CINV as no emetic episode and no use of rescue anti-nausea medication on study days 2-5.
Mary Lou Affronti, RN, MSN, ANP, MHSc
United States: Food and Drug Administration
|The Preston Robert Tisch Brain Tumor Center at Duke||Durham, North Carolina 27710|