search
Back to results

Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Pegylated liposomal doxorubicin (Caelyx)
Epirubicin
Sponsored by
Hellenic Oncology Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Advanced breast cancer, Pegylated liposomal doxorubicin, Epirubicin

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Crete
  • University General Hospital of Alexandroupolis, Dep of Medical Oncology
  • "IASO" General Hospital of Athens, 1st Dep of Medical Oncology
  • "Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
  • "Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
  • 401 Military Hospital of Athens
  • Air Forces Military Hospital of Athens
  • State General Hospital of Larissa, Dep of Medical Oncology
  • "Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
  • "Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Epi

Cael

Outcomes

Primary Outcome Measures

Assessment of antitumor efficacy by objective tumor response rates

Secondary Outcome Measures

Toxicity profile and tolerance between the two treatment arms
Time to progression
Overall survival

Full Information

First Posted
February 5, 2007
Last Updated
February 12, 2013
Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
search

1. Study Identification

Unique Protocol Identification Number
NCT00431795
Brief Title
Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
Due to poor accrual
Study Start Date
June 2003 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Advanced breast cancer, Pegylated liposomal doxorubicin, Epirubicin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Epi
Arm Title
2
Arm Type
Experimental
Arm Description
Cael
Intervention Type
Drug
Intervention Name(s)
Pegylated liposomal doxorubicin (Caelyx)
Other Intervention Name(s)
Caelyx
Intervention Description
Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m^2 IV every 4 weeks for 6 consecutive cycles
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Other Intervention Name(s)
Farmorubicine
Intervention Description
Epirubicin (Farmorubicin) at the dose of 90mg/m^2 IV every 3 weeks for 6 consecutive cycles
Primary Outcome Measure Information:
Title
Assessment of antitumor efficacy by objective tumor response rates
Time Frame
Objective responses confirmed by CT or MRI (on 3rd and 6th cy)
Secondary Outcome Measure Information:
Title
Toxicity profile and tolerance between the two treatment arms
Time Frame
Toxicity assessment of each chemotherapy cycle
Title
Time to progression
Time Frame
1 year
Title
Overall survival
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dimitris Mavrudis, MD
Organizational Affiliation
University Hospital of Crete
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Crete
City
Heraklion
State/Province
Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
University General Hospital of Alexandroupolis, Dep of Medical Oncology
City
Alexandroupolis
Country
Greece
Facility Name
"IASO" General Hospital of Athens, 1st Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine
City
Athens
Country
Greece
Facility Name
"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology
City
Athens
Country
Greece
Facility Name
401 Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
Air Forces Military Hospital of Athens
City
Athens
Country
Greece
Facility Name
State General Hospital of Larissa, Dep of Medical Oncology
City
Larissa
Country
Greece
Facility Name
"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology
City
Piraeus
Country
Greece
Facility Name
"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology
City
Thessaloniki
Country
Greece

12. IPD Sharing Statement

Learn more about this trial

Randomized Phase II Study of Epirubicin vs Caelyx in Pretreated Metastatic Breast Cancer

We'll reach out to this number within 24 hrs