Clincosm LogoSign in Get a demo

Myocet Plus Endoxan for Older Patients With Breast Cancer

Sponsor
Hellenic Oncology Research Group (Other)
Overall Status
Terminated
CT.gov ID
NCT01120171
Collaborator
(none)
64
Enrollment
11
Locations
1
Arm
67.9
Duration (Months)
5.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will evaluate the efficacy, safety and effect on quality of life of liposomal-encapsulated doxorubicin in combination with cyclophosphamide as first or second line treatment of older patients (≥ 70 years old) with metastatic breast cancer. The efficacy of the combination will be correlated with the functional status of patients according to the comprehensive geriatric assessment

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Elderly individuals make up a large part of the breast cancer population. When treated with chemotherapy for metastatic disease they derive similar benefits to their younger counterparts. Anthracyclines are associated with a cumulative dose-dependent cardiomyopathy with increased rate in patients over the age of 70. Liposomal-encapsulated doxorubicin improves the therapeutic index of doxorubicin by reducing significantly the cardiotoxicity and grade 4 neutropenia and provides comparable antitumor efficacy, when used in combination with cyclophosphamide as first-line therapy for metastatic breast cancer

Study Design

Study Type:
Interventional
Actual Enrollment :
64 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Liposome-encapsulated Doxorubicin (Myocet) Plus Cyclophosphamide as First or Second Line Therapy for Older Patients With Metastatic Breast Cancer
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
May 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Cyclofosfamide/Liposomal-encapsulated doxorubicin

Drug: Cyclophosphamide
Cyclophosphamide (IV) 600 mg/m2 on day 1. Treatment repeats every 21 days. Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy. Therapy will continue until maximum response,or unacceptable toxicity.
Other Names:
  • Endoxan

    • Drug: Liposomal-encapsulated doxorubicin
    Liposomal-encapsulated doxorubicin (IV) 50 mg/m2 on day 1. Treatment repeats every 21 days. Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy. Therapy will continue until maximum response or unacceptable toxicity.
    Other Names:
  • Myocet

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Overall Response Rate [Objective responses confirmed by CT or MRI every 3 months]

    Secondary Outcome Measures

    1. Toxicity profile [Toxicity assessment every month]

    2. Time to Tumor Progression [1-year]

    3. Overall Survival [1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically or cytologically confirmed metastatic breast adenocarcinoma

    • No more than one prior therapy regimen (other than hormonal therapy) for metastatic breast cancer is acceptable.

    • Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions)

    • Performance status (WHO) 0-2

    • Adequate liver (serum bilirubin <1.5 times the upper normal limit, AST and ALT <2.5 times the upper normal limit in the absence of demonstrable liver metastases, or <5 times the upper normal limit in the presence of liver metastases)

    • Adequate renal function (serum creatinine <1.5 times the upper normal limit)

    • Adequate cardiac function (LVEF within normal limits)

    • Adequate bone marrow function (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L)

    • No radiation of measurable disease (except brain metastases)

    • No progressive brain metastases according to clinical or radiological criteria

    • No brain metastases without prior radiation therapy

    • Written informed consent

    Exclusion Criteria:

    • Active infection

    • History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)

    • Prior treatment with an anthracycline-containing regimen (as adjuvant therapy) during the previous 12 months period

    • Other invasive malignancy except non-melanoma skin cancer

    • Psychiatric illness or social situation that would preclude study compliance

    • Pregnant or lactating women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University General Hospital of Alexandroupolis Alexandroupolis Greece
    2 "IASO" General Hospital of Athens, 1st Dep of Medical Oncology Athens Greece
    3 "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine Athens Greece
    4 "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology Athens Greece
    5 "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology Athens Greece
    6 401 Military Hospital of Athens Athens Greece
    7 Air Forces Military Hospital of Athens Athens Greece
    8 University Hospital of Crete Heraklion Greece
    9 State General Hospital of Larissa, Dep of Medical Oncology Larissa Greece
    10 "Diabalkaniko" hospital, Thessaloniki Thessaloniki Greece
    11 : "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology Thessaloniki Greece

    Sponsors and Collaborators

    • Hellenic Oncology Research Group

    Investigators

    • Principal Investigator: Dimitris Mavrudis, MD, University Hospital of Crete

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hellenic Oncology Research Group
    ClinicalTrials.gov Identifier:
    NCT01120171
    Other Study ID Numbers:
    • CT/08.32
    First Posted:
    May 10, 2010
    Last Update Posted:
    Oct 7, 2015
    Last Verified:
    Oct 1, 2015
    Keywords provided by Hellenic Oncology Research Group
    Breast cancer
    Elderly
    Chemotherapy
    Cardiotoxicity
    Additional relevant MeSH terms:
    Breast Neoplasms
    Cyclophosphamide
    Doxorubicin
    Liposomal doxorubicin

    Study Results

    No Results Posted as of Oct 7, 2015