Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to compare efficacy and tolerability of aprepitant plus dexamethasone versus metoclopramide plus dexamethasone in the prevention of cisplatin-induced delayed emesis in patients that received aprepitant, palonosetron and dexamethasone before chemotherapy administration for the prevention of acute emesis.

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

Details

• Lead Sponsor: S. Maria Hospital, Terni
• Treatments: Aprepitant; BB 1101; Cisplatin; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Fosaprepitant; Metoclopramide

Criteria

Inclusion Criteria:

1. patients receiving for the first time chemotherapy with cisplatin at doses ≥50 mg/m2.

2. patients over 18 years old and those who signed informed consent

3. adequate contraception if premenopausal women.

Every other anticancer drug in the first 24 hours will be administered after the end of cisplatin.

Exclusion Criteria:

1. patients receiving other anticancer drugs on days 2-4, except 5-fluorouracil, VP16, VM26, vincristine, vinblastine, vindesine, vinorelbine, gemcitabine

2. patients already submitted to chemotherapy with cisplatin

3. patients with concomitant severe diseases, other than neoplasm, or with predisposition to emesis such as intestinal obstruction, active peptic ulcer, hypercalcemia and brain metastases

4. contraindications to corticosteroids (i.e., active peptic ulcer or previous bleeding from peptic ulcer

5. patients submitted to concomitant radiotherapy or submitted to radiotherapy in the 15 days before chemotherapy or planned to receive radiotherapy during the 8 days after chemotherapy

6. patients receiving other concomitant antiemetic treatments or submitted to antiemetic treatments in the 24 hours before chemotherapy

7. patients with nausea or vomiting in the 24 hours before chemotherapy

8. patients receiving concomitant steroids, except when administered at physiologic dose

9. patients receiving concomitant benzodiazepines, except when used for nocturnal sedation

10. patients with WBC count <3000/mm3 or platelet count <70000/mm3

11. patients who are pregnant