Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00232505
Status:
COMPLETED
Last Update Posted:
2017-06-28
First Post:
2005-10-03
Brief Title:
Cetuximab - Carboplatin for Estrogen Receptor-Negative Progesterone Receptor-Negative Metastatic Breast Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Phase II Trial of Cetuximab Alone and in Combination With Carboplatin in ER-Negative PR-Negative HER-2 Nonoverexpressing Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-05
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 Monoclonal antibodies such as cetuximab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing It is not yet known whether giving cetuximab together with carboplatin is more effective than giving cetuximab alone in treating metastatic breast cancer
PURPOSE This randomized phase II trial is studying cetuximab and carboplatin to see how well they work compared with cetuximab alone in treating women with estrogen receptor-negative ER- progesterone receptor-negative PR- metastatic breast cancer
PURPOSE This randomized phase II trial is studying cetuximab and carboplatin to see how well they work compared with cetuximab alone in treating women with estrogen receptor-negative ER- progesterone receptor-negative PR- metastatic breast cancer
Detailed Description:
OBJECTIVES
Primary
Compare the overall response rate in women with estrogen receptor-negative progesterone receptor-negative human epidermal growth factor receptor 2 HER2-nonoverexpressing metastatic breast cancer treated with cetuximab with vs without carboplatin
Secondary
Compare the time to disease progression in patients treated with these regimens
Correlate downstream effects of epidermal growth factor receptor EGFR inhibitor on Mitogen-activated protein kinases MAPK Protein kinase B AKT monoclonal antibody Ki-67 Ki67 and EGFR-dependent signaling proliferation and apoptosis with toxicity and response in patients with accessible tumors treated with these regimens
Determine the changes in biomarkers and gene expression in circulating tumor cells during treatment
Compare the overall survival rate in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cetuximab IV over 60-120 minutes once a week
Arm II Patients receive cetuximab as in arm I and carboplatin IV on days 1 8 and 15
In both arms treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients not responding to treatment in arm I may cross over to arm II
Blood samples are collected periodically throughout study for correlative biomarker analysis by Immunohistochemistry IHC and gene expression analysis
After completion of study treatment patients are followed every 4 months
Primary
Compare the overall response rate in women with estrogen receptor-negative progesterone receptor-negative human epidermal growth factor receptor 2 HER2-nonoverexpressing metastatic breast cancer treated with cetuximab with vs without carboplatin
Secondary
Compare the time to disease progression in patients treated with these regimens
Correlate downstream effects of epidermal growth factor receptor EGFR inhibitor on Mitogen-activated protein kinases MAPK Protein kinase B AKT monoclonal antibody Ki-67 Ki67 and EGFR-dependent signaling proliferation and apoptosis with toxicity and response in patients with accessible tumors treated with these regimens
Determine the changes in biomarkers and gene expression in circulating tumor cells during treatment
Compare the overall survival rate in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cetuximab IV over 60-120 minutes once a week
Arm II Patients receive cetuximab as in arm I and carboplatin IV on days 1 8 and 15
In both arms treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity Patients not responding to treatment in arm I may cross over to arm II
Blood samples are collected periodically throughout study for correlative biomarker analysis by Immunohistochemistry IHC and gene expression analysis
After completion of study treatment patients are followed every 4 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 |
|---|---|---|---|
| CA058223 | OTHER_GRANT | NCI OSPSPOREs | httpsreporternihgovquickSearchM01RR000046 |
| M01RR000046 | NIH | None | None |