Hi Marie,
I am not sure whether you were able to access the links to trials that I posted on Friday. I thought I would paste this one in (see below), since it is specifically for brain metastases and at Dana Farber. You should be able to look at the others by clicking on the link in my post a few pages up, if you are interested. You can also look up other trials at
www.clinicaltrials.gov, as you probably know.
Good luck tomorrow! I rarely post, but I know what a warm and supportive person you are from reading your posts. I wish you and the Might Oak the best. Another website that might be useful for you (and you probably already have seen) is
www.brainmetsbc.org. Musa Meyer, who organized this site, is wonderful woman, a patient advocate and very knowledgeable and helpful. If you have any questions about what to do, I am sure she would respond to your e-mails.
All the best,
Jill
ZK219477 in Patients With Breast Cancer and Brain Metastases
This study is currently recruiting participants.
Verified by Dana-Farber Cancer Institute, January 2009
First Received: July 3, 2007 Last Updated: January 16, 2009 History of Changes
Sponsors and Collaborators: Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Bayer
Breast Cancer Research Foundation
Information provided by: Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00496379
Purpose
The purpose of this research study is to determine the effects (good and bad) of ZK219477 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.
Condition Intervention Phase
Breast Cancer
CNS Disease
Drug: ZK219477
Phase II
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title: A Phase 2 Study of ZK219477 (ZK-EPO) in Patients With Breast Cancer and Brain Metastases
Resource links provided by NLM:
Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
U.S. FDA Resources
Further study details as provided by Dana-Farber Cancer Institute:
Primary Outcome Measures:
* To evaluate the objective response rate in the CNS (complete response plus partial response) as assessed by MRI, to ZK219477 among patients with progressive brain metastases from breast cancer. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
* To determine the safety and tolerability of ZK219477 at this dose level. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
* To evaluate the objective response rate in non-CNS sites in the subset of patients with measurable non-CNS disease at baseline. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
* To evaluate time to progression at any site. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
* To evaluate 6-month progression-free survival and clinical benefit rate. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Estimated Enrollment: 37
Study Start Date: July 2007
Estimated Study Completion Date: July 2009
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
Drug: ZK219477
Given intravenously over approximately 3 hours once every 3 weeks
Detailed Description:
* Participants will be given ZK219477 intravenously over approximately 3 hours 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.
Eligibility
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Female
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria:
* Patients must have histologically or cytologically invasive breast cancer, with metastatic disease at the time of screening
* Measurable 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, WBRT, and/or 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
* Up to 3 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
* Grade 1, hormone receptive positive tumor
* 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00496379
Contacts
Contact: Nancy Lin, MD 617-632-2335
nlin@partners.org
Contact: Emily Eisenberg 617-632-6930
eeisenberg@partners.org
Locations
United States, Massachusetts
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Nancy Lin, MD
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Principal Investigator: Steven Come, MD
Sponsors and Collaborators
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Bayer
Breast Cancer Research Foundation
Investigators
Principal Investigator: Nancy Lin, MD Dana-Farber Cancer Institute
More Information
No publications provided
Responsible Party: Dana-Farber Cancer Institute ( Nancy Lin, MD )
Study ID Numbers: 06-268
Study First Received: July 3, 2007
Last Updated: January 16, 2009
ClinicalTrials.gov Identifier: NCT00496379 History of Changes
Health Authority: United States: Food and Drug
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