Ignite Creation Date:
2024-05-05 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00100854
Status:
COMPLETED
Last Update Posted:
2019-03-05
First Post:
2005-01-06
Brief Title:
Erlotinib With or Without Fulvestrant in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Translational Oncology Research International
Organization:
Translational Oncology Research International
Study Overview
Official Title:
A Randomized Open-Label Phase II Clinical Trial of Combination Erlotinib Tarceva and Fulvestrant Faslodex Versus Erlotinib Tarceva Alone in Advanced Non-Small Cell Lung Cancer Patients
Status:
COMPLETED
Status Verified Date:
2019-02
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 Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Estrogen can cause the growth of non-small cell lung cancer cells Hormone therapy using fulvestrant may fight non-small cell lung cancer by lowering the amount of estrogen the body makes Giving erlotinib together with fulvestrant may kill more tumor cells It is not yet known whether giving erlotinib together with fulvestrant is more effective than erlotinib alone in treating non-small cell lung cancer
PURPOSE This randomized phase II trial is studying giving erlotinib together with fulvestrant to see how well it works compared to erlotinib alone in treating patients with stage IIIB or stage IV non-small cell lung cancer
PURPOSE This randomized phase II trial is studying giving erlotinib together with fulvestrant to see how well it works compared to erlotinib alone in treating patients with stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare objective tumor response in patients stage IIIB or IV non-small cell lung cancer treated with erlotinib hydrochloride with vs without fulvestrant
Secondary
Correlate response rate with ER and EGF receptor expression in patients treated with these regimens
Correlate measurement of ER-α ER-β EGFHER-1 receptor and HER-2neu receptor with clinical response in patients treated with these regimens
Correlate erlotinib hydrochloride resistance with ER and HER receptor expression in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to performance status gender and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral erlotinib hydrochloride once daily on days 1-28 Courses repeat every 28 days
Arm II Patients receive erlotinib hydrochloride as in arm I and fulvestrant intramuscularly on days 1 15 and 29 and then every 28 days thereafter
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 30 days and then every 2 months until disease progression
PROJECTED ACCRUAL A total of 102 patients 34 in arm I and 68 in arm II will be accrued for this study
Primary
Compare objective tumor response in patients stage IIIB or IV non-small cell lung cancer treated with erlotinib hydrochloride with vs without fulvestrant
Secondary
Correlate response rate with ER and EGF receptor expression in patients treated with these regimens
Correlate measurement of ER-α ER-β EGFHER-1 receptor and HER-2neu receptor with clinical response in patients treated with these regimens
Correlate erlotinib hydrochloride resistance with ER and HER receptor expression in patients treated with these regimens
OUTLINE This is a randomized open-label multicenter study Patients are stratified according to performance status gender and participating center Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral erlotinib hydrochloride once daily on days 1-28 Courses repeat every 28 days
Arm II Patients receive erlotinib hydrochloride as in arm I and fulvestrant intramuscularly on days 1 15 and 29 and then every 28 days thereafter
In both arms treatment continues in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for 30 days and then every 2 months until disease progression
PROJECTED ACCRUAL A total of 102 patients 34 in arm I and 68 in arm II will be accrued for 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 |
|---|---|---|---|
| UCLA-0407058-01 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA016042 |
| P50CA090388 | NIH | None | None |
| P30CA016042 | NIH | None | None |