Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416650
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2006-12-27
Brief Title:
Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Vanderbilt-Ingram Cancer Center
Study Overview
Official Title:
Multicenter Phase II Trial of OSI-774 Erlotinib Tarceva in Patients With Advanced Bronchioalveolar Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-03
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
PURPOSE This phase II trial is studying how well erlotinib works in treating patients with advanced non-small cell lung cancer
PURPOSE This phase II trial is studying how well erlotinib works in treating patients with advanced non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the major objective response rate partial response and complete response in patients with advanced bronchoalveolar cell non-small cell lung cancer treated with erlotinib hydrochloride
Secondary
Assess the quality of life of patients treated with this regimen
Determine the duration of response and time to disease progression in patients treated with this regimen
Determine the median survival of patients treated with this regimen
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive oral erlotinib hydrochloride daily in the absence of disease progression or unacceptable toxicity
Primary
Determine the major objective response rate partial response and complete response in patients with advanced bronchoalveolar cell non-small cell lung cancer treated with erlotinib hydrochloride
Secondary
Assess the quality of life of patients treated with this regimen
Determine the duration of response and time to disease progression in patients treated with this regimen
Determine the median survival of patients treated with this regimen
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive oral erlotinib hydrochloride daily in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| GENENTECH-VU-VCC-THO-0214 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA068485 |
| P50CA090949 | NIH | None | None |
| VU-VCC-THO-0214 | None | None | None |
| P30CA068485 | NIH | None | None |
| VU-VCC-IRB-02-0168 | None | None | None |