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

NCT ID: NCT01012336

Last Updated: 2012-10-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

89 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-04-30

Brief Summary

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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

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Conditions

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Chemotherapy-Induced Nausea and Vomiting Ovarian Cancer

Keywords

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efficacy and safety of Aprepitant/Ramosetron/Dexamethasone in ovary cancer patients with taxol and carboplatin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Aprepitant

Group Type EXPERIMENTAL

Aprepitant/Ramosetron/Dexamethasone

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Duk Soo Bae, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

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Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Choi CH, Kim MK, Park JY, Yoon A, Kim HJ, Lee YY, Kim TJ, Lee JW, Kim BG, Bae DS. Safety and efficacy of aprepitant, ramosetron, and dexamethasone for chemotherapy-induced nausea and vomiting in patients with ovarian cancer treated with paclitaxel/carboplatin. Support Care Cancer. 2014 May;22(5):1181-7. doi: 10.1007/s00520-013-2070-6. Epub 2013 Dec 12.

Reference Type DERIVED
PMID: 24337621 (View on PubMed)

Other Identifiers

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2009-09-119

Identifier Type: -

Identifier Source: org_study_id