Clinical trial · Interventional
Safety and Efficacy of Aprepitant, Ramosetron, and Dexamethasone for Chemotherapy-Induced Nausea and Vomiting in Patients With Ovarian Cancer Treated With Taxane/Carboplatin
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-Induced Nausea and Vomiting | — | UNRESOLVED | — |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aprepitant/Ramosetron/Dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Aprepitant
- interventionNames
- Drug: Aprepitant/Ramosetron/Dexamethasone
Primary outcomes (2)
- 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
- description
- 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).
- measure
- Safety and Tolerability of the Aprepitant/Ramosetron/Dexamethasone Regimen
- timeFrame
- 120 hours
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDChoi 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 24337621