Epothilone B in Treating Patients With CNS Metastases From Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00450866|
Recruitment Status : Completed
First Posted : March 22, 2007
Results First Posted : October 9, 2013
Last Update Posted : February 28, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Metastatic Cancer||Biological: epothilone B||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Patupilone in Patients With Brain Metastases From Breast Cancer|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||May 2012|
|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
- Central Nervous System (CNS) Progression-free Survival(PFS) [ Time Frame: 3 months after treatment ]
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.
- Toxicity as Measured by NCI CTCAE v3.0 [ Time Frame: 3 months after treatment ]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.
- CNS Response Rate, for Measurable Disease Will be Assessed by the Modified McDonald Criteria [ Time Frame: 3 months after treatment ]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)
- Systemic Disease Response Rate for Measurable Disease Will be Assessed by the Modified McDonald Criteria [ Time Frame: 3 months after treatment ]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)
- Overall Survival [ Time Frame: 48 months from start of study ]Median time (months) that patients survived during the duration of the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00450866
|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|