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

This study has been terminated.
(We terminated the study after enrolling 580/900 patients due to a slow accrual)
Sponsor:
Information provided by (Responsible Party):
Roila Fausto, S. Maria Hospital, Terni
ClinicalTrials.gov Identifier:
NCT00869973
First received: March 25, 2009
Last updated: January 22, 2013
Last verified: October 2009
  Purpose

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 Intervention Phase
Emesis
Drug: Aprepitant
Drug: dexamethasone
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by S. Maria Hospital, Terni:

Primary Outcome Measures:
  • Percentage of complete responses (no vomiting and no rescue treatment) on days 2-5 after chemotherapy administration [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Evaluation of the impact on quality of life of the two antiemetic regimens [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]
  • Evaluation of the prognostic factors of delayed emesis in patients receiving a combination of aprepitant, palonosetron and dexamethasone for the prevention of acute emesis [ Time Frame: 6 days ] [ Designated as safety issue: Yes ]

Enrollment: 580
Study Start Date: September 2009
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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:

A) 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.

B) 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00869973

Locations
Italy
Fausto Roila
Terni, Italy, 05100
Sponsors and Collaborators
S. Maria Hospital, Terni
Investigators
Principal Investigator: Fausto Roila, MD Oncology Division, S. Maria Hospital, Terni, Italy
  More Information

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roila Fausto, Dr, S. Maria Hospital, Terni
ClinicalTrials.gov Identifier: NCT00869973     History of Changes
Other Study ID Numbers: IGAR-02-2009, 2008-001237-95
Study First Received: March 25, 2009
Last Updated: January 22, 2013
Health Authority: Italy: Ministry of Health

Keywords provided by S. Maria Hospital, Terni:
aprepitant
delayed emesis
cyclophosphamide plus anthracyclines
breast cancer
antiemetic

Additional relevant MeSH terms:
Breast Neoplasms
Vomiting
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Cyclophosphamide
Dexamethasone
Dexamethasone acetate
Aprepitant
Dexamethasone 21-phosphate
BB 1101
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014