Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer

August 4, 2009 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

A Phase II Study of Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer

Primary objective:

To determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis

Secondary objectives:

  1. To determine the overall objective response rate (ORR)
  2. To determine the progression free survival, and duration of objective response
  3. To evaluate the overall survival (OS)
  4. To assess the safety profiles

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This is an open-label, non-comparative phase II clinical trial. Approximately thirty-three patients will be enrolled in order to obtain twenty-nine evaluable subjects who received two cycles of study treatment in Simon's 2-stage optimal design.

Duration of subject involvement: Study treatment should be administered up to disease progression, intolerable toxicity, or consent withdrawal.

Recruitment period: 10 months

Study Type

Interventional

Enrollment (Actual)

2

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

  • Singapore
      • Singapore, Singapore, 308433
        • Johns Hopkins Singapore International Medical Center

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

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically or cytologically proved breast cancer
  • Relapse/recurrent brain metastasis progression after brain radiotherapy
  • Presence of brain measurable disease which is defined as at least one brain lesion that can be measured in at least 1 dimension as ³ 20 mm with magnetic resonance image (MRI)
  • Prior chemotherapy or hormone therapy for metastatic breast cancer is allowed
  • Performance status of ECOG 0, 1, 2
  • With normal left ventricular ejection fraction and normal ventricular contractility
  • Age 21 years or older
  • Life expectancy equal or longer than 3 months
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Prior anthracycline-containing chemotherapy with cumulative dose exceed 400mg/m2 doxorubicin or 750 mg/m2 Epirubicin
  • Surgery , radiotherapy, hormonal therapy or chemotherapy within 4 weeks prior to entering the study
  • Prior liposomal doxorubicin treatment
  • Concurrent chemotherapy, radiotherapy, hormonal therapy, or other investigational drug except non-disease related conditions (e.g. insulin for diabetes) during study period
  • Other malignancy with exception of curative treated non-melanoma skin cancer or cervical carcinoma in situ within 5 years prior to entering the study
  • Brain metastases defined as meninges metastases

  • Presence of serious concomitant illness which might be aggravated by study medication:

    • Uncontrolled infection (active serious infections that are not controlled by antibiotics)
    • Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study.
    • History of ventricular arrhythmia or congestive heart failure.
  • Presence of abnormal left ventricular ejection fraction

  • Hematopoietic function as defined below:

    • Hemoglobin<10g/dl
    • ANC< 1,500/uL
    • Platelets<100,000/uL

  • Organ function as defined below:

    • Total bilirubin >1.5 × ULN
    • ALT / AST>3 × ULN (>5.0 x ULN if hepatic metastasis)
    • Creatinine >1.5 × ULN
  • Mental status is not fit for clinical trial
  • Pregnant or breast feeding women, or women of child-bearing potential unless using a reliable and appropriate contraceptive method

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis
Time Frame: 3 years
3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
To determine the overall objective response rate
Time Frame: 3 years
3 years
To determine the progression free survival, and duration of objective response
Time Frame: 3 years
3 years
To evaluate the overall survival
Time Frame: 3 years
3 years
To assess the safety profiles
Time Frame: 3 years
3 years

Collaborators and Investigators

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

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

TTY Biopharm

Investigators

  • Principal Investigator: Alex Chang, Johns Hopkins Singapore International Medical Center

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

September 1, 2005

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

April 23, 2007

First Submitted That Met QC Criteria

April 24, 2007

First Posted (Estimate)

April 25, 2007

Study Record Updates

Last Update Posted (Estimate)

August 6, 2009

Last Update Submitted That Met QC Criteria

August 4, 2009

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS 0553

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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