Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women With Metastatic Breast Cancer

July 17, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

A Randomized Phase II Study of Two Different Schedules of Caelyx in Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of liposomal doxorubicin is more effective for metastatic breast cancer.

PURPOSE: Randomized phase II trial to compare the effectiveness of two regimens of liposomal doxorubicin in treating women who have metastatic breast cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the response rate in women with metastatic breast cancer treated with two different dose schedules of doxorubicin HCL liposome.
  • Assess the side effects of these treatment regimens in this patient population.
  • Determine the duration of response in these patients treated with these regimens.
  • Assess the concentration of doxorubicin in tumor tissue in patients with easily accessible metastases.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, performance status (0-1 vs 2), visceral disease (yes vs no), available lesions for biopsy (yes vs no), prior adjuvant anthracyclines (yes vs no), and prior chemotherapy for advanced disease (yes vs no). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive doxorubicin HCL liposome IV over 1 hour every 6 weeks.
  • Arm II: Patients receive doxorubicin HCL liposome IV over 1 hour every 4 weeks. Treatment continues for at least 36 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 64-100 patients (32-50 per treatment arm) will be accrued for this study.

Study Type

Interventional

Enrollment (Actual)

116

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

  • Austria
      • Vienna, Austria, A-1100
        • Ludwig Boltzmann - Institute for Applied Cancer Research
  • France
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Paris, France, 75248
        • Institut Curie - Section Medicale
      • Rouen, France, 76038
        • Centre Henri Becquerel
  • Greece
      • Ioannina, Greece, GR-45110
        • University of Ioannina
  • Israel
      • Petah-Tikva, Israel, 49100
        • Rabin Medical Center - Beilinson Campus
  • Italy
      • Milano (Milan), Italy, 20157
        • Mario Negri Institute for Pharmacological Research
      • Rome, Italy, 00161
        • Istituti Fisioterapici Ospitalieri - Roma
  • Netherlands
      • Groningen, Netherlands, 9713 EZ
        • Academisch Ziekenhuis Groningen
      • Nijmegen, Netherlands, NL-6500 HB
        • University Medical Center Nijmegen
  • Spain
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
  • Switzerland
      • Genolier, Switzerland, Ch-1272
        • Clinique De Genolier
  • United Kingdom
    • England
      • London, England, United Kingdom, SW3 6JJ
        • Royal Marsden NHS Trust

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically proven progressive or recurrent metastatic breast cancer

  • Bidimensionally measurable disease with at least one target lesion

    • If previously irradiated lesions:

      • No preirradiated only lesions
      • Clear progression prior to study
      • New lesions in a previously irradiated region allowed
  • Refusal of or medical contraindication to standard anthracycline containing regimen

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • Any age

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin normal
  • Transaminases less than 2 times upper limit of normal

Renal:

  • Creatinine normal

Cardiovascular:

  • Left ventricular ejection fraction normal by echocardiography or MUGA scan

  • No significant cardiac history including:

    • Clinically significant atrial or ventricular arrhythmias requiring treatment
    • Medically controlled congestive heart failure
    • Significant angina or clinically and/or electrocardiographically documented myocardial infarction within the past year
    • Clinically significant valvular disease

Other:

  • No other prior or concurrent malignancy within the past 5 years except contralateral breast cancer, or adequately treated basal cell skin cancer or carcinoma in situ of the cervix
  • No psychological, familial, sociological, or geographical condition that would preclude study
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • See Disease Characteristics
  • Prior adjuvant chemotherapy allowed if total doxorubicin dose is no greater than 300 mg/m2, total epirubicin dose is no greater than 450 mg/m^2, and total mitoxantrone dose is no greater than 75 mg/m^2
  • No greater than one regimen of prior chemotherapy for metastatic disease
  • No prior anthracyclines for metastatic disease
  • No other concurrent cytotoxic therapy

Endocrine therapy:

  • No concurrent hormonal therapy
  • At least 4 weeks since prior progestins, estrogens, or androgens

Radiotherapy:

  • See Disease Characteristics
  • Concurrent palliative radiotherapy allowed if sole target lesion is outside irradiated field

Surgery:

  • Not specified

Other:

  • Concurrent bisphosphonates for metastatic bone disease and hypercalcemia secondary to malignancy allowed if bony lesions not only target lesion
  • No other concurrent investigational 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Christian Dittrich, MD, Ludwig Boltzmann Institute for Applied Cancer Research at Kaiser Franz Josef Hospital
  • Study Chair: Maurizio D'Incalci, MD, Mario Negri Institute for Pharmacological Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2000

Primary Completion (Actual)

July 1, 2002

Study Registration Dates

First Submitted

July 5, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 18, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-10993-16998
  • EORTC-IDBBC-10993
  • ECSG-10993
  • PAMM-10993

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.

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