Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer - Full Text View

Sponsors and Collaborators:	Hellenic Oncology Research Group University Hospital of Crete
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00431795

Purpose

DOXORUBICIN is recognized as one of the most active drugs for breast cancer, but its clinical utility is limited because of a cumulative dose-dependent cardiac myopathy that can lead to potentially fatal congestive heart failure. Caelyx (pegylated liposomal doxorubicin) was designed to reduce the cardiotoxicity of doxorubicin while preserving its antitumor efficacy

Condition	Intervention	Phase
Breast Cancer	Drug: Pegylated liposomal doxorubicin (Caelyx) Drug: Epirubicin	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Epirubicin hydrochloride Epirubicin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:

Assessment of antitumor efficacy by objective tumor response rates [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cy) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Toxicity profile and tolerance between the two treatment arms [ Time Frame: Toxicity assessment of each chemotherapy cycle ] [ Designated as safety issue: Yes ]
Time to progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment:	182
Study Start Date:	June 2003
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Epi	Drug: Epirubicin Epirubicin (Farmorubicin) at the dose of 90mg/m^2 IV every 3 weeks for 6 consecutive cycles
2: Experimental Cael	Drug: Pegylated liposomal doxorubicin (Caelyx) Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m^2 IV every 4 weeks for 6 consecutive cycles

Detailed Description:

To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-75 years
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Adequate bone marrow function (Absolute neutrophil count >1000/mm^3, Platelet count>100000/mm^3, Hemoglobin>9gr/mm^3)
Histologically- or cytologically- confirmed breast adenocarcinoma
No prior anthracycline-based chemotherapy as treatment of advanced breast cancer
No prior chemotherapy with ≥ 300mg/m2 doxorubicin or ≥ 540mg/m2 epirubicin as adjuvant setting
At least 4 weeks interval since prior anticancer treatment
Measurable disease as defined by the presence of at least one measurable lesion(except bone metastases, ascites or pleural effusions)
Life expectancy > 3 months
Written informed consent

Exclusion Criteria:

Pregnancy or nursing
Documented history of congestive heart failure (CHF), serious arrhythmia, or myocardial infarction (within 6 months)
Other invasive malignancy except nonmelanoma skin cancer or acute infection.
Radiation of measurable disease (except brain metastases)
Progressive brain metastases according to clinical or radiological criteria.
Brain metastases without prior radiation therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00431795

Contacts

Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr
Contact: Sofia Mavraki	+30281392987	maurakh@gmail.com

Locations

Greece
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Malamos, MD
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology	Recruiting
Piraeus, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Ziras, MD
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Giassas, MD
401 Military Hospital of Athens	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Charalampos Christophillakis, MD
Air Forces Military Hospital of Athens	Recruiting
Athens, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Kentepozidis, MD
State General Hospital of Larissa, Dep of Medical Oncology	Recruiting
Larissa, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Athanasios Athanasiadis, MD
University General Hospital of Alexandroupolis, Dep of Medical Oncology	Recruiting
Alexandroupolis, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Kakolyris, MD
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology	Recruiting
Thessaloniki, Greece
Contact: George Tavoularis +302106457968 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Ioannis Boukovinas, MD
Greece, Crete
University Hospital of Crete	Recruiting
Heraklion, Crete, Greece, 71110
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Sofia Mavraki +302810392987 maurakh@gmail.gr
Principal Investigator: Dimitris Mavrudis, MD

Sponsors and Collaborators

Hellenic Oncology Research Group

University Hospital of Crete

Investigators

Principal Investigator:

Dimitris Mavrudis, MD

University Hospital of Crete

More Information

Responsible Party:	Hellenic Oncology Research Group ( D.Mavrudis )
Study ID Numbers:	CT/03.12
Study First Received:	February 5, 2007
Last Updated:	July 11, 2008
ClinicalTrials.gov Identifier:	NCT00431795
Health Authority:	Greece: National Organization of Medicines

Keywords provided by Hellenic Oncology Research Group:

Advanced breast cancer
Pegylated liposomal doxorubicin
Epirubicin

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Epirubicin
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents

Therapeutic Uses
Antibiotics, Antineoplastic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009