Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045097
Status:
COMPLETED
Last Update Posted:
2013-06-20
First Post:
2002-09-06
Brief Title:
Ixabepilone in Treating Patients With Locally Advanced or Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Clinical Trial Of BMS-247550 NSC 710428 An Epothilone B Analog In Patients With Breast Carcinoma
Status:
COMPLETED
Status Verified Date:
2007-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well ixabepilone works in treating patients with locally advanced or metastatic breast cancer
PURPOSE This phase II trial is studying how well ixabepilone works in treating patients with locally advanced or metastatic breast cancer
Detailed Description:
OBJECTIVES
Determine any antitumor activity of ixabepilone in terms of objective response rate in patients with incurable locally advanced or metastatic breast cancer
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to prior taxane therapy yes vs no
Patients with or without prior taxane exposure receive ixabepilone IV over 1 hour on days 1-5 An additional cohort of 37 patients who have received prior taxane therapy are then accrued to receive ixabepilone IV over 1 hour on days 1-3 at a higher starting dose For all patients courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients who receive more than 6 courses with satisfactory response may be treated every 4-5 weeks
Patients removed for unacceptable toxicty are followed periodically
PROJECTED ACCRUAL A total of 105 patients at least 74 with and 21 without prior taxane exposure will be accrued for this study within 26 months
Determine any antitumor activity of ixabepilone in terms of objective response rate in patients with incurable locally advanced or metastatic breast cancer
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to prior taxane therapy yes vs no
Patients with or without prior taxane exposure receive ixabepilone IV over 1 hour on days 1-5 An additional cohort of 37 patients who have received prior taxane therapy are then accrued to receive ixabepilone IV over 1 hour on days 1-3 at a higher starting dose For all patients courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients who receive more than 6 courses with satisfactory response may be treated every 4-5 weeks
Patients removed for unacceptable toxicty are followed periodically
PROJECTED ACCRUAL A total of 105 patients at least 74 with and 21 without prior taxane exposure will be accrued for this study within 26 months
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-5791 | None | None | None |
| NCI-02-C-0229 | None | None | None |