Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-01-01 @ 7:55 PM
Study NCT ID:
NCT00450866
Status:
COMPLETED
Last Update Posted:
2014-02-28
First Post:
2007-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Epothilone B in Treating Patients With CNS Metastases From Breast Cancer
Sponsor:
David Peereboom, MD
Organization:
Study Overview
Official Title:
Phase II Trial of Patupilone in Patients With Brain Metastases From Breast Cancer
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P30CA043703 | NIH | None | https://reporter.nih.gov/quic… | View |
| MSKCC-07036 | OTHER | MSKCC | View |