NCT01012336

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: Female
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chemotherapy-Induced Nausea and Vomiting
• Ovarian Cancer

Interventions

Type	Name	Description
DRUG	Aprepitant/Ramosetron/Dexamethasone	Aprepitant: The first day, one 125 mg capsule will be administered per oral, 1 hour before chemotherapy. Thereafter one 80 mg capsule will be repeated daily between 8 to 10 a.m. during days 2 to 3. Ramosetron: 0.3 mg i.v. a single dose on day 1, administered over 30 seconds, 30 minutes prior to chemotherapy. Dexamethasone: 20mg diluted in 50ml of 0.9% saline i.v. a single dose on day 1, administered over 30minutes prior to chemotherapy (taxane). Because all patients are premedicated with dexamethasone 20 mg before taxane administration, the dose of dexamethasone can not be reduced to 12 mg.

Timeline

• Start date: 2010-05-01
• Primary completion: 2011-10-01
• Completion: 2012-04-01
• First posted: 2009-11-13
• Last updated: 2012-10-10
• Results posted: 2012-10-10

Locations

1 site across 1 country: South Korea