Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin
1 other identifier
interventional
89
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 10, 2009
CompletedFirst Posted
Study publicly available on registry
November 13, 2009
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
October 10, 2012
CompletedOctober 10, 2012
October 1, 2012
1.4 years
November 10, 2009
August 29, 2012
October 8, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen
120 hours
Secondary Outcomes (2)
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
Time to First Vomiting Episode or Use of Rescue Medication
120 hours
Study Arms (1)
Aprepitant
EXPERIMENTALInterventions
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 Criteria
You may qualify if:
- patient is over 18 years
- ovarian carcinoma patients who are treated with moderately emetogenic chemotherapy
- Karnofsky score \> 60
- Life expectancy \> 4 months
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Samsung Medical Centerlead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
Related Publications (1)
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.
PMID: 24337621DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pf Duk-Soo Bae
- Organization
- Samsung Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Duk Soo Bae, MD, PhD
Samsung Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2009
First Posted
November 13, 2009
Study Start
May 1, 2010
Primary Completion
October 1, 2011
Study Completion
April 1, 2012
Last Updated
October 10, 2012
Results First Posted
October 10, 2012
Record last verified: 2012-10