ZK219477 in Patients With Breast Cancer and Brain Metastases
Status: Recruiting
Phase: Phase 2
Diagnosis: Brain/Neuro Cancer: Other Non-Glioblastoma, Breast: Metastatic
NCT ID: NCT00496379
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 06-268
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.
Conducting Institutions:
Dana-Farber Cancer Institute, Beth-Israel Deaconess Medical Center, Brigham and Women's Hospital
Overall PI:
Nancy Lin, MD,
Dana-Farber Cancer Institute
Site-responsible Investigators:
Steven Come, MD,
Beth Israel Deaconess Medical Center
Contacts:
Dana-Farber Cancer Institute:
Breast Cancer Nursing Team, 617-632-3478
Beth-Israel Deaconess Medical Center:
Cancer Trials Call Center, 617-667-3060
Eligibility 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.