Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054132
Status:
COMPLETED
Last Update Posted:
2017-07-24
First Post:
2003-02-05
Brief Title:
Erlotinib Hydrochloride and Bevacizumab in Treating Patients With Stage IV Breast Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of OSI-774 in Combination With Bevacizumab in Patients With Stage IV Breast Cancer
Status:
COMPLETED
Status Verified Date:
2017-06
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 studies how well erlotinib hydrochloride and bevacizumab work in treating patients with stage IV breast cancer Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Monoclonal antibodies such as bevacizumab may interfere with the ability of tumor cells to grow and spread Giving erlotinib hydrochloride and bevacizumab may be an effective treatment for breast cancer
Detailed Description:
PRIMARY OBJECTIVES
I To determine the efficacy of bevacizumab in combination with OSI-774 erlotinib hydrochloride in patients with previously treated metastatic breast cancer as measured by objective response rate
SECONDARY OBJECTIVES
I To determine the toxicity of bevacizumab in combination with OSI-774 in patients with previously treated metastatic breast cancer
II To evaluate the efficacy of bevacizumab in combination with OSI-774 in patients with previously treated metastatic breast cancer as measured by time to disease progression duration of response and the proportion of patients with stabilization of disease 6 months
III To determine the molecular profile of the patients primary breast tumor and to explore the relationship between these molecular characteristics and the response to treatment
IV To explore changes in biological markers in pre- and post-treatment tumor tissue in a subset of patients with accessible sites of disease
V To explore a pre- and post-treatment analysis of circulating endothelial cells and the relationship of this analysis to serum markers of angiogenesis as well as response to treatment
VI To obtain serial measurements of circulating epithelial cells and explore the relationship of these cells with circulating endothelial cells markers of angiogenesis and epidermal growth factor receptor EGFR expression
OUTLINE
Patients receive erlotinib hydrochloride orally PO once daily QD on days 1-21 and bevacizumab intravenously IV over 30-90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
I To determine the efficacy of bevacizumab in combination with OSI-774 erlotinib hydrochloride in patients with previously treated metastatic breast cancer as measured by objective response rate
SECONDARY OBJECTIVES
I To determine the toxicity of bevacizumab in combination with OSI-774 in patients with previously treated metastatic breast cancer
II To evaluate the efficacy of bevacizumab in combination with OSI-774 in patients with previously treated metastatic breast cancer as measured by time to disease progression duration of response and the proportion of patients with stabilization of disease 6 months
III To determine the molecular profile of the patients primary breast tumor and to explore the relationship between these molecular characteristics and the response to treatment
IV To explore changes in biological markers in pre- and post-treatment tumor tissue in a subset of patients with accessible sites of disease
V To explore a pre- and post-treatment analysis of circulating endothelial cells and the relationship of this analysis to serum markers of angiogenesis as well as response to treatment
VI To obtain serial measurements of circulating epithelial cells and explore the relationship of these cells with circulating endothelial cells markers of angiogenesis and epidermal growth factor receptor EGFR expression
OUTLINE
Patients receive erlotinib hydrochloride orally PO once daily QD on days 1-21 and bevacizumab intravenously IV over 30-90 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up periodically
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 |
|---|---|---|---|
| P30CA008748 | NIH | CTEP | httpsreporternihgovquickSearchP30CA008748 |
| NCI-2013-02225 | REGISTRY | None | None |
| CDR0000269900 | None | None | None |
| 02-119 | None | None | None |
| MSKCC-02119 | None | None | None |
| NCI-5761 | None | None | None |
| 02-119 | OTHER | None | None |
| 5761 | OTHER | None | None |
| N01CM17105 | NIH | None | None |