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

Sponsor:	Sidney Kimmel Comprehensive Cancer Center
Collaborator:	TTY Biopharm
Information provided by:	Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00465673

Purpose

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

Condition	Intervention	Phase
Breast Cancer	Drug: Liposomal Doxorubicin	Phase II

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:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

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:

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

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 February 09, 2012