Aprepitant for the Prevention of Chemotherapy-induced Nausea and Vomiting

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To compare the antiemetic combination of palonosetron, dexamethasone, and aprepitant (PDA) with antiemetic combination of palonosetron and dexamethasone (PD) in nasopharyngeal carcinoma patients receiving docetaxel, cisplatin, and 5-FU based chemotherapy.

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

Details

• Lead Sponsor: Wuhan Union Hospital, China
• Treatments: Aprepitant; BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Palonosetron

Criteria

Inclusion Criteria:

1. 18 years of age or older

2. Histologically or cytologically confirmed nasopharyngeal carcinoma

3. Accept chemotherapy for the first time

4. Patients who will receive chemotherapy (docetaxel 60 mg/m2 intravenously (IV), cisplatin 60 mg/m2 IV, and 5-FU (5-Fluorouracil) 600 mg/m2 IV)

5. Written informed consent

Exclusion Criteria:

1. regnant 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