RATIONALE: Drugs used in chemotherapy, such as epothilone B, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well epothilone B works in treating patients with CNS metastases from breast cancer.
OBJECTIVES: Primary * Determine the 3-month CNS-progression free survival of patients with CNS metastases secondary to breast cancer treated with epothilone B. Secondary * Determine the toxicity of this drug in these patients. * Determine the CNS response rate and duration of CNS response in patients treated with this drug. * Determine the systemic disease response rate and duration of systemic response in patients treated with this drug. * Determine the overall survival of patients treated with this drug. OUTLINE: This is a multicenter, open-label study. Patients receive epothilone B IV over 20 minutes on day 1. Courses repeat every 21 days in the absence of disease progression, satisfactory response, or unacceptable toxicity. After completion of study treatment, patients are followed periodically. PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
55
Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Central Nervous System (CNS) Progression-free Survival(PFS)
The number of patients that are documented to have progression free survival at 3 months after treatment. Progression free is define as \<25% increase in tumor area. PFS will be measured from the date of entry into the trial to the date of documented progression of brain metastases or death.
Time frame: 3 months after treatment
Toxicity as Measured by NCI CTCAE v3.0
Percent of patients that experience the most common grade 3 and above toxicities possibly related to study drug - to be measured using the NCI Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0.
Time frame: 3 months after treatment
CNS Response Rate, for Measurable Disease Will be Assessed by the Modified McDonald Criteria
Complete Response (CR): the circumstance when the tumor is no longer seen by neuroimaging Partial Response (PR): Decrease of \>50% in the product of two diameters Stable Disease (SD): the circumstance when the scan shows no change. Progression (P): a \> 25% increase in tumor area (two diameters)
Time frame: 3 months after treatment
Systemic Disease Response Rate for Measurable Disease Will be Assessed by the Modified McDonald Criteria
Complete Response (CR): the circumstance when the tumor is no longer seen by neuroimaging Partial Response (PR): Decrease of \>50% in the product of two diameters Stable Disease (SD): the circumstance when the scan shows no change. Progression (P): a \> 25% increase in tumor area (two diameters)
Time frame: 3 months after treatment
Overall Survival
Median time (months) that patients survived during the duration of the study.
Time frame: 48 months from start of study
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Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States