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

This study has been terminated.
(Low recruitment)
Sponsor:
Collaborator:
TTY Biopharm
Information provided by:
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00465673
First received: April 23, 2007
Last updated: August 4, 2009
Last verified: August 2009
  Purpose

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

Condition Intervention Phase
Breast Cancer
Drug: Liposomal Doxorubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the overall objective response rate [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To determine the progression free survival, and duration of objective response [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To evaluate the overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess the safety profiles [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Enrollment: 2
Study Start Date: September 2005
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Liposomal Doxorubicin
    40mg/m2 over 1 hour infusion for 21 days
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465673

Locations
Singapore
Johns Hopkins Singapore International Medical Center
Singapore, Singapore, 308433
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
TTY Biopharm
Investigators
Principal Investigator: Alex Chang Johns Hopkins SIngapore International Medical Center
  More Information

No publications provided

Responsible Party: Alex Chang, Johns Hopkins Singapore International Medical Center
ClinicalTrials.gov Identifier: NCT00465673     History of Changes
Other Study ID Numbers: JS 0553
Study First Received: April 23, 2007
Last Updated: August 4, 2009
Health Authority: Singapore: Health Sciences Authority
United States: Institutional Review Board

Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
breast cancer
brain metastatsis
Lipo-Dox

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes
Doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014