Status:
TERMINATED
Liposomal Doxorubicin (Lipo-Dox) in Patients With Brain Metastasis From Breast Cancer
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
TTY Biopharm
Conditions:
Breast Cancer
Eligibility:
FEMALE
21+ years
Phase:
PHASE2
Brief Summary
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...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT00465673
Start Date
September 1 2005
End Date
July 1 2009
Last Update
August 6 2009
Active Locations (1)
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1
Johns Hopkins Singapore International Medical Center
Singapore, Singapore, 308433