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Sponsors and Collaborators: |
Hellenic Oncology Research Group University Hospital of Crete |
Information provided by: | Hellenic Oncology Research Group |
ClinicalTrials.gov Identifier: | NCT00431795 |
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 |
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 |
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
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Drug: Epirubicin
Epirubicin (Farmorubicin) at the dose of 90mg/m^2 IV every 3 weeks for 6 consecutive cycles
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2: Experimental
Cael
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Drug: Pegylated liposomal doxorubicin (Caelyx)
Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m^2 IV every 4 weeks for 6 consecutive cycles
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To compare the efficacy of pegylated liposomal doxorubicin versus epirubicin as second line chemotherapy in patient with advanced breast cancer
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Dora Hatzidaki | +302810392570 | dorachat@med.uoc.gr |
Contact: Sofia Mavraki | +30281392987 | maurakh@gmail.com |
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 |
Hellenic Oncology Research Group |
University Hospital of Crete |
Principal Investigator: | Dimitris Mavrudis, MD | University Hospital of Crete |
Responsible Party: | Hellenic Oncology Research Group ( D.Mavrudis ) |
Study ID Numbers: | CT/03.12 |
First Received: | February 5, 2007 |
Last Updated: | July 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00431795 |
Health Authority: | Greece: National Organization of Medicines |
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