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| Sponsor: | Case Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00450866 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer Metastatic Cancer |
Biological: epothilone B |
Phase 2 |
| Study Type: | Interventional |
| 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 |
| Estimated Enrollment: | 55 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | December 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
CNS metastases (i.e., brain parenchymal lesions and/or leptomeningeal disease), meeting 1 of the following criteria:
Recurrent or progressive CNS metastases after whole brain radiotherapy
PATIENT CHARACTERISTICS:
No unresolved diarrhea within the past 7 days
No contraindications to MRI, including any of the following:
PRIOR CONCURRENT THERAPY:
No concurrent Coumadin® or other agents containing warfarin
No concurrent radiotherapy for central metastases (e.g., vertebral or mediastinal metastases)
Contacts and Locations| 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 |
More Information
| Responsible Party: | David M. Peereboom, MD, Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00450866 History of Changes |
| Other Study ID Numbers: | CASE5106, P30CA043703, MSKCC-07036 |
| Study First Received: | March 20, 2007 |
| Last Updated: | July 25, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
recurrent breast cancer stage IV breast cancer tumors metastatic to brain leptomeningeal metastases male breast cancer |
|
Breast Neoplasms Neoplasm Metastasis Neoplasms Neoplasms, Second Primary Neoplasms by Site Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes |
Epothilone B Epothilones Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |