ZK219477 (Sagopilone) in Patients With Breast Cancer and Brain Metastases
Condition: Breast Cancer; CNS Disease
MeSH terms: Breast Neoplasms; Neoplasm Metastasis; Brain Neoplasms; Central Nervous System Diseases
Intervention: ZK219477
Intervention description: Given intravenously over approximately 30 minutes once every 3 weeks
Intervention MeSH terms: Epothilones; Sagopilone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: metastatic breast cancer; invasive breast cancer; brain metastases; ZK-EPO

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.
    

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.