Clinical trial NCT00465673: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: breast cancer
brain metastatsis
Lipo-Dox
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: TTY Biopharm
First posted: 2007-04-25
Enrollment: 2
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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. To determine the progression free survival, and duration of objective response
3. To evaluate the overall survival (OS)
4. 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

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

Primary outcomes:
measure: Determine the brain response rate of Lipo-Dox in breast cancer patients with brain metastasis
timeFrame: 3 years
Secondary outcomes:
measure: To determine the overall objective response rate
timeFrame: 3 years
measure: To determine the progression free survival, and duration of objective response
timeFrame: 3 years
measure: To evaluate the overall survival
timeFrame: 3 years
measure: To assess the safety profiles
timeFrame: 3 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Johns Hopkins Singapore International Medical Center
Study officials:
affiliation: Johns Hopkins SIngapore International Medical Center
name: Alex Chang
role: PRINCIPAL_INVESTIGATOR
References: