Epothilone B in Treating Patients With CNS Metastases From Breast Cancer
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Patupilone in Patients With Brain Metastases From Breast Cancer|
- CNS progression-free survival and overall survival [ Time Frame: 3 months after treatment ] [ Designated as safety issue: No ]
- Toxicity as measured by NCI CTCAE v3.0 [ Time Frame: after treatment ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2007|
|Study Completion Date:||May 2012|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
|Experimental: Epothilone B||
Biological: epothilone B
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.
Other Name: Patupilone
- Determine the 3-month CNS-progression free survival of patients with CNS metastases secondary to breast cancer treated with epothilone B.
- 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.
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|University of Michigan Comprehensive Cancer Center|
|Ann Arbor, Michigan, United States, 48109|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Ohio|
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||David M. Peereboom, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Principal Investigator:||Joseph Baar, MD||Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center|