Myocet Plus Endoxan for Older Patients With Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Hellenic Oncology Research Group
Sponsor:
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT01120171
First received: May 5, 2010
Last updated: June 21, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Cyclophosphamide
Drug: Liposomal-encapsulated doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI every 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity profile [ Time Frame: Toxicity assessment every month ] [ Designated as safety issue: Yes ]
  • Time to Tumor Progression [ Time Frame: 1-year ] [ Designated as safety issue: No ]
  • Overall Survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 46
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01120171

Contacts
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Eva Maragkoudaki +302810392857 dorachat@med.uoc.gr

Locations
Greece
University General Hospital of Alexandroupolis Recruiting
Alexandroupolis, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Stelios Kakolyris, MD         
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine Recruiting
Athens, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Aris Polyzos, MD         
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology Recruiting
Athens, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Nikos Ziras, MD         
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology Recruiting
Athens, Greece
Contact: Spyros Georgiadis    +302106442666    secretary@horg.gr   
Principal Investigator: Nikos Malamos, MD         
401 Military Hospital of Athens Recruiting
Athens, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Charalampos Christophillakis, MD         
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology Recruiting
Athens, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Stelios Giassas, MD         
Air Forces Military Hospital of Athens Recruiting
Athens, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Nikos Kentepozidis, MD         
University Hospital of Crete Recruiting
Heraklion, Greece
Contact: Dora Hatzidaki    +302810392570    dorachat@med.uoc.gr   
Contact: Eva Maragkoudaki    +302810392857    dorachat@med.uoc.gr   
Sub-Investigator: Manolis Saloustros, MD         
State General Hospital of Larissa, Dep of Medical Oncology Recruiting
Larissa, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Athanasios Athanasiadis, MD         
: "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology Recruiting
Thessaloniki, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Ioannis Boukovinas, MD         
"Diabalkaniko" hospital, Thessaloniki Recruiting
Thessaloniki, Greece
Contact: Spyros Georgiadis    +302106448666    secretary@horg.gr   
Principal Investigator: Christos Emmanouilidis, MD         
Sponsors and Collaborators
Hellenic Oncology Research Group
Investigators
Principal Investigator: Dimitris Mavrudis, MD University Hospital of Crete
  More Information

No publications provided

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT01120171     History of Changes
Other Study ID Numbers: CT/08.32
Study First Received: May 5, 2010
Last Updated: June 21, 2014
Health Authority: Greece: National Organization of Medicines

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
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 31, 2014