NCT00431795

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Jun 2003

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

February 5, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 6, 2007

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

February 13, 2013

Status Verified

February 1, 2013

Enrollment Period

9 years

First QC Date

February 5, 2007

Last Update Submit

February 12, 2013

Conditions

Breast Cancer

Keywords

Advanced breast cancerPegylated liposomal doxorubicinEpirubicin

Outcome Measures

Primary Outcomes (1)

  • Assessment of antitumor efficacy by objective tumor response rates

    Objective responses confirmed by CT or MRI (on 3rd and 6th cy)

Secondary Outcomes (3)

  • Toxicity profile and tolerance between the two treatment arms

    Toxicity assessment of each chemotherapy cycle

  • Time to progression

    1 year

  • Overall survival

    1 year

Study Arms (2)

1

EXPERIMENTAL

Epi

Drug: Epirubicin

2

EXPERIMENTAL

Cael

Drug: Pegylated liposomal doxorubicin (Caelyx)

Interventions

Pegylated liposomal doxorubicin (Caelyx)DRUG

Pegylated liposomal Doxorubicin (Caelyx) at the dose of 50mg/m\^2 IV every 4 weeks for 6 consecutive cycles

Also known as: Caelyx
2
EpirubicinDRUG

Epirubicin (Farmorubicin) at the dose of 90mg/m\^2 IV every 3 weeks for 6 consecutive cycles

Also known as: Farmorubicine
1

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University Hospital of Crete

Heraklion, Crete, 71110, Greece

Location

University General Hospital of Alexandroupolis, Dep of Medical Oncology

Alexandroupoli, Greece

Location

"IASO" General Hospital of Athens, 1st Dep of Medical Oncology

Athens, Greece

Location

"Laikon" General Hospital, Medical Oncology Unit, Propedeutic Dep of Internal Medicine

Athens, Greece

Location

"Marika Iliadis" Hospital of Athens, Dep of Medical Oncology

Athens, Greece

Location

401 Military Hospital of Athens

Athens, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

State General Hospital of Larissa, Dep of Medical Oncology

Larissa, Greece

Location

"Metaxa's" Anticancer Hospital of Piraeus, 1st Dep of Medical Oncology

Piraeus, Greece

Location

"Theagenion" Anticancer Hospital of Thessaloniki, 2nd Dep of Medical Oncology

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicinEpirubicin

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DoxorubicinDaunorubicinAnthracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsAminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Dimitris Mavrudis, MD

    University Hospital of Crete

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2007

First Posted

February 6, 2007

Study Start

June 1, 2003

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 13, 2013

Record last verified: 2013-02

Locations

GR(10)