Chemotherapy-Induced Nausea and Vomiting, Ovarian Cancer
Conditions
Keywords
efficacy and safety of Aprepitant/Ramosetron/Dexamethasone in ovary cancer patients with taxol and carboplatin
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.
Interventions
DRUGAprepitant/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.
Sponsors
Merck Sharp & Dohme LLC
Samsung Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 80 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 120 hours | 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 | 120 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aprepitant Aprepitant is a selective, high-affinity NK1 receptor antagonist | 85 |
| Total | 85 |
Baseline characteristics
| Characteristic | Aprepitant |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 69 Participants |
| Age Continuous | 54.9 years STANDARD_DEVIATION 12.1 |
| Region of Enrollment Korea, Republic of | 85 participants |
| Sex: Female, Male Female | 85 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 35 / 89 |
| serious Total, serious adverse events | 2 / 89 |
Outcome results
Primary
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).
Time frame: 120 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Aprepitant | 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. | 89.4 Percentage of Participants |
Primary
Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen
Time frame: 120 hours
Secondary
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
Secondary
Time to First Vomiting Episode or Use of Rescue Medication
Time frame: 120 hours