Status:
TERMINATED
Aprepitant in the Prevention of Cisplatin-induced Delayed Emesis
Lead Sponsor:
S. Maria Hospital, Terni
Conditions:
Emesis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
This is a phase III, double-blind, randomized trial, to evaluated the efficacy and safety of aprepitant for the prevention of delayed emesis in patients submitted for the first time to chemotherapy wi...
Eligibility Criteria
Inclusion
- patients receiving for the first time chemotherapy with cisplatin at doses ≥50 mg/m2.
- patients over 18 years old and those who signed informed consent
- adequate contraception if premenopausal women.
- Every other anticancer drug in the first 24 hours will be administered after the end of cisplatin.
Exclusion
- patients receiving other anticancer drugs on days 2-4, except 5-fluorouracil, VP16, VM26, vincristine, vinblastine, vindesine, vinorelbine, gemcitabine
- patients already submitted to chemotherapy with cisplatin
- patients with concomitant severe diseases, other than neoplasm, or with predisposition to emesis such as intestinal obstruction, active peptic ulcer, hypercalcemia and brain metastases
- contraindications to corticosteroids (i.e., active peptic ulcer or previous bleeding from peptic ulcer
- 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
- patients receiving other concomitant antiemetic treatments or submitted to antiemetic treatments in the 24 hours before chemotherapy
- patients with nausea or vomiting in the 24 hours before chemotherapy
- patients receiving concomitant steroids, except when administered at physiologic dose
- patients receiving concomitant benzodiazepines, except when used for nocturnal sedation
- patients with WBC count \<3000/mm3 or platelet count \<70000/mm3
- patients who are pregnant
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT00869310
Start Date
September 1 2009
End Date
May 1 2012
Last Update
January 6 2014
Active Locations (1)
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1
Fausto Roila
Terni, Terni, Italy, 05100