Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer
February 12, 2013 updated by: Hellenic Oncology Research Group
A Multicenter Randomized Phase II Study of Second Line Chemotherapy With Epirubicin( Farmorubicin) Versus the Pegylated Liposomal Doxorubicin in Advanced Breast Cancer Patients
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
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Alexandroupolis, Greece
- University General Hospital of Alexandroupolis, Dep of Medical Oncology
-
Athens, Greece
- "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
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Athens, Greece
- "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
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Athens, Greece
- "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
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Athens, Greece
- 401 Military Hospital of Athens
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Athens, Greece
- Air Forces Military Hospital of Athens
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Larissa, Greece
- State General Hospital of Larissa, Dep of Medical Oncology
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Piraeus, Greece
- "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
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Thessaloniki, Greece
- "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
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Crete
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Heraklion, Crete, Greece, 71110
- University Hospital of Crete
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
Epi
|
Epirubicin (Farmorubicin) at the dose of 90mg/m^2 IV every 3 weeks for 6 consecutive cycles
Other Names:
|
|
Experimental: 2
Cael
|
Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m^2 IV every 4 weeks for 6 consecutive cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Assessment of antitumor efficacy by objective tumor response rates
Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
|
Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall survival
Time Frame: 1 year
|
1 year
|
|
Time to progression
Time Frame: 1 year
|
1 year
|
|
Toxicity profile and tolerance between the two treatment arms
Time Frame: Toxicity assessment of each chemotherapy cycle
|
Toxicity assessment of each chemotherapy cycle
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2003
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
February 5, 2007
First Submitted That Met QC Criteria
February 5, 2007
First Posted (Estimate)
February 6, 2007
Study Record Updates
Last Update Posted (Estimate)
February 13, 2013
Last Update Submitted That Met QC Criteria
February 12, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT/03.12
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.