Status:
TERMINATED
Aprepitant in the Prevention of Delayed Emesis Induced by Cyclophosphamide Plus Anthracyclines in Breast Cancer Patients
Lead Sponsor:
S. Maria Hospital, Terni
Conditions:
Emesis
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The aim of the study is to compare efficacy and tolerability of aprepitant versus dexamethasone in the prevention of delayed emesis induced by moderately emetogenic chemotherapy (cyclophosphamide plus...
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 with breast cancer submitted for the first time...
Eligibility Criteria
Inclusion
- patients with breast cancer, receiving for the first time chemotherapy with cyclophosphamide + anthracyclines (FAC, FEC, AC, EC).
- 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 cyclophosphamide plus anthracycline.
Exclusion
- patients already submitted to chemotherapy
- patients receiving any chemotherapy on days 2-4 after treatment
- patients with concomitant severe diseases 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 doses
- 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 or breast-feeding
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
580 Patients enrolled
Trial Details
Trial ID
NCT00869973
Start Date
September 1 2009
End Date
July 1 2012
Last Update
January 23 2013
Active Locations (1)
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1
Fausto Roila
Terni, Terni, Italy, 05100