Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033514
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2002-04-09
Brief Title:
Trastuzumab and Erlotinib as First-Line Therapy in Treating Women With Metastatic Breast Cancer Associated With HER2Neu Overexpression
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Jonsson Comprehensive Cancer Center
Study Overview
Official Title:
Phase III Study Of Herceptin Combined With OSI-774 In The First-Line Treatment Of Metastatic Breast Cancer Associated With HER2Neu Overexpression
Status:
COMPLETED
Status Verified Date:
2016-02
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 trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Biological therapies such as erlotinib may interfere with the growth of tumor cells and slow the growth of the tumor Combining trastuzumab with erlotinib may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2neu overexpression
PURPOSE Phase II trial to study the effectiveness of combining trastuzumab with erlotinib as first-line therapy in treating women who have metastatic breast cancer associated with HER2neu overexpression
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and recommended phase II dose of erlotinib when combined with trastuzumab Herceptin as first-line therapy in women with metastatic breast cancer associated with HER2neu overexpression Phase I closed to accrual as of 012004
Determine the safety profile of this regimen in these patients
Determine the rate and duration of objective response in patients treated with this regimen
Determine the pharmacologic behavior of this regimen in these patients
Determine time to disease progression and duration of survival in patients treated with this regimen
Correlate the antitumor activity of this regimen with epidermal growth factor receptor expression in these patients
OUTLINE This is a dose-escalation study of erlotinib Phase I closed to accrual as of 012004
Patients receive oral erlotinib once daily beginning on day 2 and trastuzumab Herceptin IV over 30-90 minutes 1-4 hours after erlotinib once weekly beginning on day 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the recommended phase II dose
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for the phase I portion closed to accrual as of 012004 and 27-81 patients will be accrued for the phase II portion of this study
Determine the maximum tolerated dose and recommended phase II dose of erlotinib when combined with trastuzumab Herceptin as first-line therapy in women with metastatic breast cancer associated with HER2neu overexpression Phase I closed to accrual as of 012004
Determine the safety profile of this regimen in these patients
Determine the rate and duration of objective response in patients treated with this regimen
Determine the pharmacologic behavior of this regimen in these patients
Determine time to disease progression and duration of survival in patients treated with this regimen
Correlate the antitumor activity of this regimen with epidermal growth factor receptor expression in these patients
OUTLINE This is a dose-escalation study of erlotinib Phase I closed to accrual as of 012004
Patients receive oral erlotinib once daily beginning on day 2 and trastuzumab Herceptin IV over 30-90 minutes 1-4 hours after erlotinib once weekly beginning on day 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Once the MTD is determined additional patients are treated at the recommended phase II dose
Patients are followed every 2 months
PROJECTED ACCRUAL A total of 3-18 patients will be accrued for the phase I portion closed to accrual as of 012004 and 27-81 patients will be accrued for the phase II portion of this study
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-G02-2057 | None | None | None |
| CDR0000069295 | None | None | None |
| GENENTECH-OSI2365s | None | None | None |