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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012336
• Other study ID #: 2009-09-119
• Status: Completed
• Phase: Phase 2
• First received: November 10, 2009
• Last updated: October 8, 2012
• Start date: May 2010
• Est. completion date: April 2012

Study information

• Verified date: October 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: April 2012
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 80 Years

Eligibility

Inclusion criteria

1. patient is over 18 years

2. ovarian carcinoma patients who are treated with moderately emetogenic chemotherapy

3. Karnofsky score > 60

4. Life expectancy > 4 months

Exclusion criteria

1. Any of following conditions (mentally incapacitated or emotional or psychiatric disorder, user of any illicit drugs, has an active infection, hypersensitivity to ramosetron or aprepitant)

2. Patients have received a nonapproved drug within last 4 weeks

3. abnormal laboratory values (AST > 2.5 normal, ALT > 2.5 normal, Bilirubin > 1.5 normal, Creatinine > 1.5 normal)

4. Antiemetic drugs within 48 hours of study

5. Benzodiazepine or opiate within 48 hours

6. CYP3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)

7. CYP3A4 inhibitors (clarithromycin, ketoconazole)

8. CYP3A4 inducers within 30 days (Barbiturates, rifampicin, carbamazepine)

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chemotherapy-Induced Nausea and Vomiting
• Nausea
• Ovarian Cancer
• Ovarian Neoplasms
• Vomiting

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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).	120 hours	Yes
Primary	Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen		120 hours	Yes
Secondary	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	Yes
Secondary	Time to First Vomiting Episode or Use of Rescue Medication		120 hours	Yes