Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059852
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2003-05-06
Brief Title:
Erlotinib and Gemcitabine in Treating Patients With Metastatic Breast Cancer Previously Treated With An Anthracycline andor a Taxane
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Study of OSI-774 Tarceva and Gemcitabine for Patients With Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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:
RATIONALE Drugs used in chemotherapy such as gemcitabine work in different ways to stop tumor cells from dividing so they stop growing or die Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth Combining gemcitabine with erlotinib may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine with erlotinib in treating patients who have metastatic breast cancer that has been previously treated with an anthracycline andor a taxane
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine with erlotinib in treating patients who have metastatic breast cancer that has been previously treated with an anthracycline andor a taxane
Detailed Description:
OBJECTIVES
Determine the anti-tumor activity of erlotinib and gemcitabine in patients with metastatic breast cancer previously treated with anthracycline andor taxane
Determine the adverse event profile of this regimen in these patients
Determine whether epidermal growth factor receptor and HER-2 receptor intensity and serum concentrations have an impact on clinical response in patients treated with this regimen
Determine the impact of genetic differences in proteins involved in drug response transport metabolism and mechanism of action on clinical response and adverse events associated with gemcitabine in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV on days 1 and 8 and oral erlotinib on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients achieving a complete response are followed every 6 weeks for up to 5 years or until disease progression PD Patients discontinuing study therapy for any other reason are followed every 3 months until PD and then every 6 months for up to 5 years
Determine the anti-tumor activity of erlotinib and gemcitabine in patients with metastatic breast cancer previously treated with anthracycline andor taxane
Determine the adverse event profile of this regimen in these patients
Determine whether epidermal growth factor receptor and HER-2 receptor intensity and serum concentrations have an impact on clinical response in patients treated with this regimen
Determine the impact of genetic differences in proteins involved in drug response transport metabolism and mechanism of action on clinical response and adverse events associated with gemcitabine in these patients
OUTLINE This is a multicenter study
Patients receive gemcitabine IV on days 1 and 8 and oral erlotinib on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients achieving a complete response are followed every 6 weeks for up to 5 years or until disease progression PD Patients discontinuing study therapy for any other reason are followed every 3 months until PD and then every 6 months for up to 5 years
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-2012-02529 | REGISTRY | None | None |
| CDR0000298778 | REGISTRY | PDQ Physician Data Query | None |