Spots Global Cancer Trial Database for Epothilone B in Treating Patients With CNS Metastases From Breast Cancer
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Trial Identification
Brief Title: Epothilone B in Treating Patients With CNS Metastases From Breast Cancer
Official Title: Phase II Trial of Patupilone in Patients With Brain Metastases From Breast Cancer
Study ID: NCT00450866
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center, Cleveland, Ohio, United States
Contact Details
Name: David M. Peereboom, MD
Affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
Name: Joseph Baar, MD
Affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Role: PRINCIPAL_INVESTIGATOR
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