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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Liposomal Doxorubicin
Sponsored by
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, brain metastatsis, Lipo-Dox

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Singapore International Medical Center

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

To determine the overall objective response rate
To determine the progression free survival, and duration of objective response
To evaluate the overall survival
To assess the safety profiles

Full Information

First Posted
April 23, 2007
Last Updated
August 4, 2009
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
TTY Biopharm
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1. Study Identification

Unique Protocol Identification Number
NCT00465673
Brief Title
Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer
Official Title
A Phase II Study of Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
September 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
TTY Biopharm

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Primary objective: To determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis Secondary objectives: To determine the overall objective response rate (ORR) To determine the progression free survival, and duration of objective response To evaluate the overall survival (OS) To assess the safety profiles
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, brain metastatsis, Lipo-Dox

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Liposomal Doxorubicin
Intervention Description
40mg/m2 over 1 hour infusion for 21 days
Primary Outcome Measure Information:
Title
Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis
Time Frame
3 years
Secondary Outcome Measure Information:
Title
To determine the overall objective response rate
Time Frame
3 years
Title
To determine the progression free survival, and duration of objective response
Time Frame
3 years
Title
To evaluate the overall survival
Time Frame
3 years
Title
To assess the safety profiles
Time Frame
3 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Chang
Organizational Affiliation
Johns Hopkins SIngapore International Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Singapore International Medical Center
City
Singapore
ZIP/Postal Code
308433
Country
Singapore

12. IPD Sharing Statement

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

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