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Myocet Plus Endoxan for Older Patients With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01120171
Recruitment Status : Terminated (Due to poor accrual)
First Posted : May 10, 2010
Last Update Posted : October 7, 2015
Sponsor:
Information provided by (Responsible Party):

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
Breast Cancer Drug: Cyclophosphamide Drug: Liposomal-encapsulated doxorubicin 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  (Clinical Trial)
Actual Enrollment : 64 participants
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 : September 2009
Primary Completion Date : May 2015
Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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 Name: 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 Name: Myocet


Outcome Measures

Primary Outcome Measures :
  1. Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI every 3 months ]

Secondary Outcome Measures :
  1. Toxicity profile [ Time Frame: Toxicity assessment every month ]
  2. Time to Tumor Progression [ Time Frame: 1-year ]
  3. Overall Survival [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01120171


Locations
Greece
University General Hospital of Alexandroupolis
Alexandroupolis, Greece
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
Athens, Greece
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
Athens, Greece
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
Athens, Greece
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
Athens, Greece
401 Military Hospital of Athens
Athens, Greece
Air Forces Military Hospital of Athens
Athens, Greece
University Hospital of Crete
Heraklion, Greece
State General Hospital of Larissa, Dep of Medical Oncology
Larissa, Greece
"Diabalkaniko" hospital, Thessaloniki
Thessaloniki, Greece
: "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
More Information

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT01120171     History of Changes
Other Study ID Numbers: CT/08.32
First Posted: May 10, 2010    Key Record Dates
Last Update Posted: October 7, 2015
Last Verified: October 2015

Keywords provided by Hellenic Oncology Research Group:
Breast cancer
Elderly
Chemotherapy
Cardiotoxicity

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors