drugset / Trial / NCT01012336

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

NCT01012336

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2010-05
Primary completion
2011-10
Completion
2012-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Aprepitant Other / unclassified 80 mg Oral
Subject Dexamethasone Small molecule 20 mg Intravenous
Subject Ramosetron Small molecule 0.3 mg Intravenous