Ignite Creation Date:
2024-05-05 @ 11:36 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087412
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
2004-07-08
Brief Title:
S0341 Erlotinib in Treating Patients With Advanced Primary Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of OSI-774 NSC-718781 in Patients With Advanced Non-Small Cell Lung Cancer and a Performance Status of 2
Status:
COMPLETED
Status Verified Date:
2013-02
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:
This phase II trial is studying how well erlotinib works in treating patients with advanced primary non-small cell lung cancer Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth
Detailed Description:
PRIMARY OBJECTIVES
I To assess survival in patients with advanced non-small cell lung carcinoma with a Zubrod Performance Status of 2 treated with OSI-774
II To evaluate the objective tumor response rates confirmed plus unconfirmed complete and partial in patients with advanced non-small cell lung carcinoma with a Zubrod Performance Status of 2 treated with OSI-774
III To investigate in a preliminary manner possible correlations of EGFR expression mutations andor EGFR polymorphisms with response andor survival
IV To investigate in a preliminary manner possible correlations of activated signal pathway molecules including basal p27 expression levels with response andor survival
OUTLINE This is a multicenter study
Patients receive oral erlotinib once daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
I To assess survival in patients with advanced non-small cell lung carcinoma with a Zubrod Performance Status of 2 treated with OSI-774
II To evaluate the objective tumor response rates confirmed plus unconfirmed complete and partial in patients with advanced non-small cell lung carcinoma with a Zubrod Performance Status of 2 treated with OSI-774
III To investigate in a preliminary manner possible correlations of EGFR expression mutations andor EGFR polymorphisms with response andor survival
IV To investigate in a preliminary manner possible correlations of activated signal pathway molecules including basal p27 expression levels with response andor survival
OUTLINE This is a multicenter study
Patients receive oral erlotinib once daily on days 1-21 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 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 |
|---|---|---|---|
| S0341 | None | None | None |
| U10CA032102 | NIH | None | None |
| CDR0000377245 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA032102 |