Overview

Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin

Status:
Completed
Trial end date:
2012-04-01
Target enrollment:
Participant gender:
Summary
The current recommended guideline for patients receiving moderately emetogenic chemotherapy (MEC) is the combination of a 5-HT3 receptor antagonist and corticosteroid. Incidence of chemotherapy induced nausea and vomiting (CINV) is approximately 50% in patients receiving MEC. An incidence rate of 25-38% for delayed emesis and 55-60% for delayed nausea has been observed. Hence, there is clearly a need for more effective prevention of CINV in patients receiving MEC, especially in women with ovarian carcinoma who are particularly susceptible to these symptoms. Therefore the investigators designed a study with the objective to evaluate if new combination (Aprepitant/Ramosetron/Dexamethasone) may improve actual CINV control in ovarian carcinoma patients treated with taxane/carboplatin.
Phase:
Phase 2
Details
Lead Sponsor:
Samsung Medical Center
Collaborator:
Merck Sharp & Dohme Corp.
Treatments:
Aprepitant
BB 1101
Carboplatin
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Fosaprepitant
Ramosetron
Taxane