Aprepitant in the Prevention of Delayed Emesis Induced by Cyclophosphamide Plus Anthracyclines in Breast Cancer Patients

Sponsor

S. Maria Hospital, Terni (Other)

Overall Status

Terminated

CT.gov ID

NCT00869973

Collaborator

(none)

580

Enrollment

Location

Arms

Duration (Months)

17.1

Patients Per Site Per Month

Study Details

Study Description

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 anthracyclines) in breast cancer patients.

Condition or Disease	Intervention/Treatment	Phase
Emesis	Drug: Aprepitant Drug: dexamethasone	Phase 3

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 to chemotherapy with cyclophosphamide plus anthracyclines.

The study will be carried out during the first cycle of chemotherapy.

For the prevention of acute emesis, all patients will receive, before chemotherapy:

dexamethasone 8 mg iv in 15 minutes, 30 minutes before chemotherapy;
palonosetron 0.25 mg iv bolus, 30 minutes before chemotherapy
aprepitant 125 mg orally, 60 minutes before chemotherapy

After 24 hours from chemotherapy administration, patients will be randomized to receive:

dexamethasone 4 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on day 3.
Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3.

The patients will receive prochlorperazine suppositories as rescue medication, for important nausea and vomiting (> 2 episodes) during days 1-5 after chemotherapy.

The patients will receive a diary, which includes a Visual Analogue Scale (VAS) for nausea and vomiting evaluation. All patients will fill out the diary in which, for 6 consecutive days (days 1-6), patients will report for each day the number of vomiting episodes, the intensity and duration of nausea, any antiemetic rescue medication and any adverse event and its treatment.

In addition, on day 1 before chemotherapy and then on day 6, patients will fill out the FLIE (Functional Living Index-Emesis), a questionnaire concerning the impact of nausea and vomiting on their quality of life.

Primary end point is the percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after chemotherapy administration

Study Design

Study Type:

Interventional

Actual Enrollment :

580 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Aprepitant in the Prevention of Delayed Emesis Induced by Moderately Emetogenic Chemotherapy (Cyclophosphamide Plus Anthracyclines) in Breast Cancer Patients: a Double-blind Randomized Study

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Aprepitant	Drug: Aprepitant Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3
Active Comparator: 2 dexamethasone	Drug: dexamethasone dexamethasone 4 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on day 3

Arm

Intervention/Treatment

Experimental: 1

Aprepitant

Drug: Aprepitant

Aprepitant 80 mg orally: 24 hours after chemotherapy on day 2 and then at 8 am on day 3

Active Comparator: 2

dexamethasone

Drug: dexamethasone

dexamethasone 4 mg orally: 24 hours after chemotherapy and at 8 pm on day 2, then at 8 am and 8 pm on day 3

Outcome Measures

Primary Outcome Measures

Percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after chemotherapy administration [6 days]

Secondary Outcome Measures

Evaluation of the impact on quality of life of the two antiemetic regimens [6 days]
Evaluation of the prognostic factors of delayed emesis in patients receiving a combination of aprepitant, palonosetron and dexamethasone for the prevention of acute emesis [6 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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