Ramosetron, Aprepitant and Dexamethasone (RAD) in Solid Cancer
Status:
Unknown status
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
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%.
Aprepitant is a selective, high-affinity NK1 receptor antagonist. Adding aprepitant to 5-HT3
receptor antagonists and steroid improve CR rate of not only chemotherapy induced acute
emesis and but also delayed emesis by 11-14 and 20 percentage points, respectively.
But until now, there was no information that which 5-HT3 receptor antagonists is the best
partner for aprepitant. Therefore, we initiated a prospective, open-label, phase II study to
assess the efficacy and tolerability of a combination of ramosetron, aprepitant and
dexamethasone (RAD) in the prevention of cisplatin based CINV in chemotherapy-naïve patients
with solid cancer