A Phase II Study to Evaluate the Efficacy and Tolerability of Ramosetron, Aprepitant and Dexamethasone (RAD) in Preventing Cisplatin-induced Nausea and Vomiting in Chemotherapy-naïve Patients With Solid Cancer
Cisplatin is one of the most emetogenic drugs used in clinical practice and it could result
in poor compliance with chemotherapy. The 5-HT3 receptor antagonists prevent vomiting in
acute phase emesis after chemotherapy in 73 - 92% of cisplatin-treated patients when
coadministered with steroids, but they appear to lack efficacy in the delayed phase emesis.
Ramosetron, a new 5-HT3 receptor antagonists, has been shown to have equivalent efficacy and
tolerability and a longer duration of effect than granisetron in preventing acute vomiting
in patients undergoing cisplatin-containing chemotherapy. Acute phase emesis was prevented
in 84.8% of patients receiving ramosetron plus dexamethasone, but the CR rate of total phase
emesis was less than 60%.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Complete response (CR) rate of RAD for the prevention of chemotherapy induced nausea vomiting (CINV) during overall phase (form 1 to 5 days) (overall phase is defined as acute and delayed phase)
from chemotherapy day 1 to day 5
Hyo Jung Kim, M.D.
Hallym University Medical Center
Korea: Institutional Review Board