Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Harbin Medical University
• Collaborator: Harbin Medical University
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Olanzapine; Palonosetron

Criteria

Inclusion Criteria:

1. 18 years of age or older

2. Histologically or cytologically confirmed malignant disease

3. Accept chemotherapy for the first time

4. 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，ifosfam ide>=2g/m2) or moderate emetogenic chemotherapy cancer (carboplatin>=300mg/m2,cyclophosphamide>=600-1000mg/m2,adriamycin>50mg/m2)

5. Written informed consent

Exclusion Criteria:

1. Pregnant or breast-feeding

2. Uncontrolled psychosis history

3. Inability or unwillingness to understand or cooperate with study procedures

4. Central nervous system tumors primary or secondary

5. Concurrent abdominal radiotherapy

6. History of uncontrolled diabetes mellitus

7. Patients of prostatic hyperplasia ，paralytic ileus，narrow feet glaucoma.

8. Known cardiac arrhythmia, uncontrolled congestive heart failure ,or acute myocardial infarction with the previous six month

9. Pre-existing nausea or vomiting

10. Inadequate hematological function and abnormal liver and renal function.

11. History of sensitivity to olanzapine

12. Concurrent application of quinolone antibiotic therapy

13. Treatment with another antipsychotic agent such as risperidone,quetiapine, clozapine,phenothiazine,or butyrophenone for 30 days prior to or during the chemotherapy.

14. Cytochrome P450 3A4 substrates within 7 days (terfenadine, cisapride, astemizole, pimozide)

15. Concurrent application of systemic corticosteroids

16. Active infection or gastrointestinal dysfunction