Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-28 @ 6:36 PM
Study NCT ID:
NCT00416650
Status:
COMPLETED
Last Update Posted:
2013-04-04
First Post:
2006-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erlotinib in Treating Patients With Advanced Non-Small Cell Lung Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
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:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P50CA090949 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA068485 | NIH | None | https://reporter.nih.gov/quic… | View |
| VU-VCC-THO-0214 | None | None | View | |
| VU-VCC-IRB-02-0168 | None | None | View | |
| GENENTECH-VU-VCC-THO-0214 | None | None | View |