Back to resultsZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases
Primary Purpose
Breast Cancer, CNS Disease
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ZK219477
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring metastatic breast cancer, invasive breast cancer, brain metastases, ZK-EPO
Eligibility Criteria
Inclusion Criteria:
- Patients must have histologically or cytologically invasive breast cancer, with metastatic disease at the time of screening
- Measurable Central Nervous System (CNS) disease, as defined as at least one lesion > or equal too 10mm in longest dimension
- New or progressive CNS lesions after at least one prior standard CNS-directed therapy for treatment of brain metastases, which could include surgical resection, whole brain radiotherapy (WBRT), and/or stereotactic radiosurgery (SRS). Patients must have received prior WBRT, SRS or both.
- Patient has been evaluated by a radiation oncologist, who feels that the plan to evaluate systemic chemotherapy in place of additional brain radiotherapy is an acceptable option
- No increase in corticosteroid use in the week prior to study entry
- Any number prior lines of chemotherapy for metastatic breast cancer
- 18 years of age of older
- Life expectancy of greater than 12 weeks
- ECOG Performance Status 0-2
- Patients must have normal organ function as outlined in the protocol
Exclusion Criteria:
- Patients who have had chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
- Patients who have had XRT within 3 weeks prior to entering the study or those who have not recovered from adverse events due to XRT
- Patients may not be receiving any other investigational agent
- Patients may not be receiving any cancer-directed therapy
- Prior treatment with investigational chemotherapy for brain metastases
- Prior treatment with epothilone for metastatic breast cancer
- Leptomeningeal carcinomatosis as the only site of CNS involvement.
- Concurrent treatment with an enzyme inducing antiepileptic drug, including phenytoin, carbamezepine, phenobarbital, or oxacarbazepine
- More than 2 seizures over the last four weeks prior to study entry
- Known contraindication to MRI or gadolinium contrast, such as cardiac pacemaker, ocular foreign body, or shrapnel
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant or breastfeeding women.
Sites / Locations
- Dana-Farber Cancer Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ZK219477
Arm Description
Outcomes
Primary Outcome Measures
Objective Response Rate in the Central Nervous System (CNS)
Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.
Secondary Outcome Measures
Number of Subjects With Adverse Events (Any Grade)
Adverse events per NCI CTCAE
Objective Response Rate in Non-Central Nervous System (CNS) Sites
Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease
Time to Progression at Any Site.
Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0
Clinical Benefit Rate.
CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease
Full Information
NCT ID
NCT00496379
First Posted
July 3, 2007
Last Updated
March 12, 2013
Sponsor
Nancy Lin, MD
Collaborators
Brigham and Women's Hospital, Bayer, Breast Cancer Research Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00496379
Brief Title
ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases
Official Title
A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
This study has closed to accrual early due to slow accrual.
Study Start Date
July 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
January 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nancy Lin, MD
Collaborators
Brigham and Women's Hospital, Bayer, Breast Cancer Research Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research study is to determine the effects (good and bad) of ZK219477(sagopilone) on participants and their cancer. ZK219477 is a chemotherapy drug that is thought to work by interfering with the ability of cancer cells to grow and divide. It is a part of a group of drugs called "epothilones" which appear to cause shrinkage of cancer in some patients with breast cancer. It is generally difficult for chemotherapy to enter the brain. However, it is believed that ZK219477 crosses into the brain. We are also studying whether an investigational MRI scan procedure may eventually help to predict which patients will benefit from ZK219477.
Detailed Description
Participants will be given ZK219477 intravenously over approximately 30 minutes every three weeks.
During all treatment cycles a physical exam and questions about the participants general health and specific questions about any problems they may be having will be performed.
At least every three weeks blood tests will be done to assess the effect of ZK219477 on the body.
After every 2 cycles of treatment, participants will have additional scans to assess the effect of ZK219477 on their cancer. This will include a CT scan of the abdomen, chest, and pelvis, and an MRI of the brain.
At the time of the standard MRI, participants will be asked to undergo an additional MRI sequence, which means they will be in the MRI machine for approximately 15-20 more minutes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, CNS Disease
Keywords
metastatic breast cancer, invasive breast cancer, brain metastases, ZK-EPO
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ZK219477
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
ZK219477
Other Intervention Name(s)
ZK-EPO, ZK-Epothilone, Sagopilone
Intervention Description
Given intravenously over approximately 30 minutes once every 3 weeks
Primary Outcome Measure Information:
Title
Objective Response Rate in the Central Nervous System (CNS)
Description
Objective response rate is defined as at least a 50 percent reduction in the Central Nervous system target lesion volume compared to the lesion volume at baseline.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of Subjects With Adverse Events (Any Grade)
Description
Adverse events per NCI CTCAE
Time Frame
2 years
Title
Objective Response Rate in Non-Central Nervous System (CNS) Sites
Description
Non-CNS response rate (according to RECIST 1.0) limited to patients with measurable non-CNS disease
Time Frame
2 years
Title
Time to Progression at Any Site.
Description
Time from date of registration until the date of the first documentation of progression or date of death (from any cause),whichever came first, up to 2 years from registration. Progression is defined as either progression in the Central Nervous system (CNS) according to volumetric measurement (Freedman et al. 2011) and /or progression in non-Central Nervous System lesion Measured by RECIST 1.0
Time Frame
2 years
Title
Clinical Benefit Rate.
Description
CBR = CR + PR + SD > 24 weeks in CNS with at least stable non-CNS disease
Time Frame
2 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have histologically or cytologically invasive breast cancer, with metastatic disease at the time of screening
Measurable Central Nervous System (CNS) disease, as defined as at least one lesion > or equal too 10mm in longest dimension
New or progressive CNS lesions after at least one prior standard CNS-directed therapy for treatment of brain metastases, which could include surgical resection, whole brain radiotherapy (WBRT), and/or stereotactic radiosurgery (SRS). Patients must have received prior WBRT, SRS or both.
Patient has been evaluated by a radiation oncologist, who feels that the plan to evaluate systemic chemotherapy in place of additional brain radiotherapy is an acceptable option
No increase in corticosteroid use in the week prior to study entry
Any number prior lines of chemotherapy for metastatic breast cancer
18 years of age of older
Life expectancy of greater than 12 weeks
ECOG Performance Status 0-2
Patients must have normal organ function as outlined in the protocol
Exclusion Criteria:
Patients who have had chemotherapy within 3 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
Patients who have had XRT within 3 weeks prior to entering the study or those who have not recovered from adverse events due to XRT
Patients may not be receiving any other investigational agent
Patients may not be receiving any cancer-directed therapy
Prior treatment with investigational chemotherapy for brain metastases
Prior treatment with epothilone for metastatic breast cancer
Leptomeningeal carcinomatosis as the only site of CNS involvement.
Concurrent treatment with an enzyme inducing antiepileptic drug, including phenytoin, carbamezepine, phenobarbital, or oxacarbazepine
More than 2 seizures over the last four weeks prior to study entry
Known contraindication to MRI or gadolinium contrast, such as cardiac pacemaker, ocular foreign body, or shrapnel
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or breastfeeding women.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nancy Lin, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases
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