Clinical trial NCT01012336: Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chemotherapy-Induced Nausea and Vomiting
Ovarian Cancer
Keywords: efficacy and safety of Aprepitant/Ramosetron/Dexamethasone in ovary cancer patients with taxol and carboplatin
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2009-11-13
Enrollment: 89
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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)

Primary outcomes:
measure: 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.
timeFrame: 120 hours
measure: Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen
timeFrame: 120 hours
Secondary outcomes:
measure: 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
timeFrame: 120 hours
measure: Time to First Vomiting Episode or Use of Rescue Medication
timeFrame: 120 hours
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Duk Soo Bae, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.