Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077376
Status:
COMPLETED
Last Update Posted:
2014-05-21
First Post:
2004-02-10
Brief Title:
Trastuzumab Ixabepilone and Carboplatin in Treating Patients With HER2Neu-Positive Metastatic Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Trial of Trastuzumab Plus Weekly IxabepiloneBMS-247550 and Carboplatin in Patients With HER2Neu-Positive Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2012-12
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:
This phase II trial is studying how well giving trastuzumab together with ixabepilone and carboplatin works in treating patients with HER2neu-positive metastatic breast cancer Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy such as ixabepilone and carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die Combining trastuzumab with ixabepilone and carboplatin may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To determine the response rate as determined by RECIST criteria to combination therapy with Ixabepilone BMS-247550 trastuzumab and carboplatin in patients with metastatic breast cancer known to overexpress HER2
SECONDARY OBJECTIVES
I To determine time to disease progression TTP and time to treatment failure TTF after treatment with Ixabepilone BMS-247550 trastuzumab and carboplatin in patients with metastatic breast cancer known to overexpress HER2
II To determine the toxicity of combination therapy with Ixabepilone BMS-247550 trastuzumab and carboplatin in patients with metastatic breast cancer known to overexpress HER2
III To evaluate overall survival OS of combination therapy with Ixabepilone BMS-247550 trastuzumab and carboplatin in patients with metastatic breast cancer known to overexpress HER2
IV To correlate levels of phospho-STAT3 with levels of HER2 Survivin and EGFR expression as measured in tissue by immunohistochemistry
OUTLINE This is a multicenter study
Induction therapy Patients receive trastuzumab Herceptin IV over 30 minutes on days 1 8 15 and 22 and ixabepilone IV over 1 hour and carboplatin IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity
NOTE Trastuzumab is given over 90 minutes on day 1 of course 1 induction therapy only
Maintenance therapy Patients receive trastuzumab IV over 90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years from study entry
PROJECTED ACCRUAL A total of 10-60 patients will be accrued for this study within 1-6 months
I To determine the response rate as determined by RECIST criteria to combination therapy with Ixabepilone BMS-247550 trastuzumab and carboplatin in patients with metastatic breast cancer known to overexpress HER2
SECONDARY OBJECTIVES
I To determine time to disease progression TTP and time to treatment failure TTF after treatment with Ixabepilone BMS-247550 trastuzumab and carboplatin in patients with metastatic breast cancer known to overexpress HER2
II To determine the toxicity of combination therapy with Ixabepilone BMS-247550 trastuzumab and carboplatin in patients with metastatic breast cancer known to overexpress HER2
III To evaluate overall survival OS of combination therapy with Ixabepilone BMS-247550 trastuzumab and carboplatin in patients with metastatic breast cancer known to overexpress HER2
IV To correlate levels of phospho-STAT3 with levels of HER2 Survivin and EGFR expression as measured in tissue by immunohistochemistry
OUTLINE This is a multicenter study
Induction therapy Patients receive trastuzumab Herceptin IV over 30 minutes on days 1 8 15 and 22 and ixabepilone IV over 1 hour and carboplatin IV over 1 hour on days 1 8 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of unacceptable toxicity
NOTE Trastuzumab is given over 90 minutes on day 1 of course 1 induction therapy only
Maintenance therapy Patients receive trastuzumab IV over 90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 3 years from study entry
PROJECTED ACCRUAL A total of 10-60 patients will be accrued for this study within 1-6 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-2012-02946 | REGISTRY | None | None |
| U10CA023318 | NIH | None | None |
| E2103 | OTHER | None | None |
| E2103 | OTHER | None | None |
| U10CA021115 | NIH | CTEP | httpsreporternihgovquickSearchU10CA021115 |