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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00465673
• Other study ID #: JS 0553
• Status: Terminated
• Phase: Phase 2
• First received: April 23, 2007
• Last updated: August 4, 2009
• Start date: September 2005
• Est. completion date: July 2009

Study information

• Verified date: August 2009
• Source: Sidney Kimmel Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences AuthorityUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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. To determine the progression free survival, and duration of objective response

3. To evaluate the overall survival (OS)

4. To assess the safety profiles

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Liposomal Doxorubicin
40mg/m2 over 1 hour infusion for 21 days

Locations

Country	Name	City	State
Singapore	Johns Hopkins Singapore International Medical Center	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center	TTY Biopharm

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis		3 years	No
Secondary	To determine the overall objective response rate		3 years	No
Secondary	To determine the progression free survival, and duration of objective response		3 years	No
Secondary	To evaluate the overall survival		3 years	No
Secondary	To assess the safety profiles		3 years	Yes