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

Phase 2

Completed

• Conditions: Chemotherapy-Induced Nausea and Vomiting; Ovarian Cancer
• Interventions: Drug: Aprepitant/Ramosetron/Dexamethasone

• Registration Number: NCT01012336
• Lead Sponsor: Samsung Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-11-10
• Study First Submitted QC: 2009-11-12
• Study First Posted: 2009-11-13
• Study Start: 2010-05
• Primary Completion: 2011-10
• Study Completion: 2012-04
• Results First Submitted: 2012-08-29
• Status Verified: 2012-10
• Results First Submitted QC: 2012-10-08
• Last Update Submitted: 2012-10-08
• Results First Posted: 2012-10-10
• Last Update Posted: 2012-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 89

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aprepitant	Aprepitant/Ramosetron/Dexamethasone	-

Primary Outcome Measures

Name	Time	Method
Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With a Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy.	120 hours	Complete Response is defined as No vomiting with no rescue therapy. These response criteria will be applied to the following time periods: Overall: from 0 (chemotherapy initiation) to the morning of day 6, Acute: 0 to 24 hours following the initiation of chemotherapy, Delayed: 25 hours to the morning of day 6(D6).
Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen	120 hours

Secondary Outcome Measures

Name	Time	Method
Efficacy of the Aprepitant/Ramosetron/Dexamethasone Regimen in Terms of the Proportion of Patients With no Vomiting During the 120 Hour Following Initiation of Chemotherapy	120 hours
Time to First Vomiting Episode or Use of Rescue Medication	120 hours

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of