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

Sponsor:	Samsung Medical Center
Collaborator:	Merck
Information provided by:	Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT01012336

Purpose

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.

Condition	Intervention	Phase
Chemotherapy-Induced Nausea and Vomiting Ovarian Cancer	Drug: Aprepitant/Ramosetron/Dexamethasone	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Nausea and Vomiting Ovarian Cancer

Drug Information available for: Dexamethasone Carboplatin Dexamethasone acetate Doxiproct plus Ramosetron YM 060 Aprepitant Dexamethasone Sodium Phosphate

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:

Efficacy of the Aprepitant/Ramosetron/Dexamethasone regimen in terms of the proportion of patients with a CR during the 120 hour following initiation of chemotherapy [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Safety and tolerability of the Aprepitant/Ramosetron/Dexamethasone regimen [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

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 [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Time to first vomiting episode or use of rescue medication [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	96
Study Start Date:	May 2010
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Intervention Details:

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.

Eligibility

Ages Eligible for Study:	20 Years to 80 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria

patient is over 18 years
ovarian carcinoma patients who are treated with moderately emetogenic chemotherapy
Karnofsky score > 60
Life expectancy > 4 months

Exclusion criteria

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)
Patients have received a nonapproved drug within last 4 weeks
abnormal laboratory values (AST > 2.5 normal, ALT > 2.5 normal, Bilirubin > 1.5 normal, Creatinine > 1.5 normal)
Antiemetic drugs within 48 hours of study
Benzodiazepine or opiate within 48 hours
CYP3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
CYP3A4 inhibitors (clarithromycin, ketoconazole)
CYP3A4 inducers within 30 days (Barbiturates, rifampicin, carbamazepine)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012336

Contacts

Contact: Duk soo Bae, M.D.

82-2-3410-3519

ds123.bae@samsung.com

Locations

Korea, Republic of
Samsung Medical Center	Not yet recruiting
Seoul, Korea, Republic of
Contact: duk soo bae, M.D. Ph.D 82-2-3410-3518 ds123.bae@samsung.com
Contact: min kyu kim, M.D. 82-2-3410-3518 minkyu72.kim@samsung.com

Sponsors and Collaborators

Samsung Medical Center

Merck

Investigators

Principal Investigator:

Duk Soo Bae, MD, PhD

Samsung Medical Center

More Information

No publications provided

Responsible Party:	Duk So Bae/Chairman of Dept. of Ob. & Gyn., Samsung Medical Center
ClinicalTrials.gov Identifier:	NCT01012336 History of Changes
Other Study ID Numbers:	2009-09-119
Study First Received:	November 10, 2009
Last Updated:	May 17, 2010
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:

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

Additional relevant MeSH terms:

Nausea
Vomiting
Ovarian Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders

Dexamethasone acetate
Dexamethasone
Ramosetron
Aprepitant
Dexamethasone 21-phosphate
Carboplatin
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012