Phase 3
Completed N=120
Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting
Source: ClinicalTrials.gov NCT02484911 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Proportion of Participants Receiving HEC With Complete Response in Overall Phase — 20; 15 Participants — p=0.397
◆ Published Evidence
Highly cited
251citations · ~11 / year
Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists.
Summary
The purpose of the study is to mainly evaluate the efficacy and safety of aprepitant in combination with olanzapine ,palonosetron and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly or moderately emetogenic chemotherapy.
Linked Publications (5)
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Differential involvement of neurotransmitters through the time course of cisplatin-induced emesis as revealed by therapy with specific receptor antagonists.
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Control of chemotherapy-induced emesis.
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Potential of substance P antagonists as antiemetics.
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Aprepitant plus palonosetron and dexamethasone for prevention of chemotherapy-induced nausea and vomiting in patients receiving multiple-day cisplatin chemotherapy.
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Emerging treatments in chemotherapy-induced nausea and vomiting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Receiving HEC With Complete Response in Overall Phase |
20; 15 | 0.397 |
| PRIMARY Proportion of Participants Receiving MEC With Complete Response in Overall Phase |
36; 40 | 1.0 |
| SECONDARY Proportion of Participants Receiving HEC With Complete Response in the Acute Phase |
20; 17 | — |
| SECONDARY Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase |
20; 15 | 0.397 |
| SECONDARY Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase |
17; 6 | 0.02 sig |
| SECONDARY Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase |
18; 15 | 1.0 |
| SECONDARY Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase |
17; 7 | 0.005 sig |
| SECONDARY Proportion of Participants Receiving MEC With Complete Response in the Acute Phase |
36; 41 | — |
| SECONDARY Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase |
36; 40 | 1.0 |
| SECONDARY Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase |
30; 30 | 0.283 |
| SECONDARY Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase |
35; 40 | 1.0 |
| SECONDARY Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase |
30; 31 | 0.246 |
Eligibility Criteria
Inclusion Criteria
- 18 years of age or older
- Histologically or cytologically confirmed malignant disease
- Accept chemotherapy for the first time
- Patients who will receive high emetogenic cancer chemotherapy (HEC) (cisplatin>=70mg/m2,adriamycin in combination with cyclophosphamide ,cyclophosphamide>=1500mg/m2,adriamycin>60mg/m2,epirubicin>90mg/m2,dacarbazine，ifosfamide>=2g/m2) or moderate emetogenic chemotherapy cancer (carboplatin>=300mg/m2,cyclophosphamide>=600-1000mg/m2,adriamycin>50mg/m2)
- Written informed consent
Exclusion Criteria
- Pregnant or breast-feeding
- Uncontrolled psychosis history
- Inability or unwillingness to understand or cooperate with study procedures
- Central nervous system tumors primary or secondary
- Concurrent abdominal radiotherapy
- History of uncontrolled diabetes mellitus
- Patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma.
- Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month
- Pre-existing nausea or vomiting
- Inadequate hematological function and abnormal liver and renal function.
- History of sensitivity to olanzapine
- Concurrent application of quinolone antibiotic therapy
- Treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy.
- Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)
- Concurrent application of systemic corticosteroids
- Active infection or gastrointestinal dysfunction
Data sourced from ClinicalTrials.gov (NCT02484911) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.