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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01012336
First received: November 10, 2009
Last updated: October 8, 2012
Last verified: October 2012
  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 2

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:


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 Complete Response (CR) During the 120 Hour Following Initiation of Chemotherapy. [ Time Frame: 120 hours ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 120 hours ] [ 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: 120 hours ] [ Designated as safety issue: Yes ]
  • Time to First Vomiting Episode or Use of Rescue Medication [ Time Frame: 120 hours ] [ Designated as safety issue: Yes ]

Enrollment: 89
Study Start Date: May 2010
Study Completion Date: April 2012
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aprepitant 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.


  Eligibility

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

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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01012336

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Duk Soo Bae, MD, PhD Samsung Medical Center
  More Information

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01012336     History of Changes
Other Study ID Numbers: 2009-09-119
Study First Received: November 10, 2009
Results First Received: August 29, 2012
Last Updated: October 8, 2012
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:
Ovarian Neoplasms
Nausea
Vomiting
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Carboplatin
Dexamethasone
Dexamethasone acetate
Aprepitant
Fosaprepitant
Ramosetron
Dexamethasone 21-phosphate
BB 1101
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014