Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00085280
Status:
COMPLETED
Last Update Posted:
2014-03-31
First Post:
2004-06-10
Brief Title:
Erlotinib in Treating Patients With Stage IIIB Stage IV or Recurrent Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Pilot Study to Determine if Downstream Markers of EGFR Linked Signaling Pathways Predict Response to OSI-774 Erlotinib in the First-Line Treatment of Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-01
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 clinical trial is studying how well erlotinib works in treating patients with stage IIIB stage IV or recurrent 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 Prospectively identify downstream markers of EGFR linked signaling pathways that are predictive of response to OSI-774 Erlotinib in this population
SECONDARY OBJECTIVES
I Estimate antitumor objective response rate per RECIST II Estimate disease control rate CRPRSD III Estimate time to progression and overall survival IV Estimate if a grade 2 rash is a predictor of response to OSI-774 Erlotinib and of patient survival
V Assess safety profile of OSI-774 Erlotinib in this population VI To determine whether smoking status is linked to outcome for advanced NSCLC patients treated with OSI-774 Erlotinib
OUTLINE This is a pilot multicenter study
Patients receive oral erlotinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients complete the Smoking Status Survey a questionnaire regarding smoking habits at baseline and then every 3 months during study treatment
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 129 patients will be accrued for this study within 6 months
I Prospectively identify downstream markers of EGFR linked signaling pathways that are predictive of response to OSI-774 Erlotinib in this population
SECONDARY OBJECTIVES
I Estimate antitumor objective response rate per RECIST II Estimate disease control rate CRPRSD III Estimate time to progression and overall survival IV Estimate if a grade 2 rash is a predictor of response to OSI-774 Erlotinib and of patient survival
V Assess safety profile of OSI-774 Erlotinib in this population VI To determine whether smoking status is linked to outcome for advanced NSCLC patients treated with OSI-774 Erlotinib
OUTLINE This is a pilot multicenter study
Patients receive oral erlotinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients complete the Smoking Status Survey a questionnaire regarding smoking habits at baseline and then every 3 months during study treatment
After completion of study treatment patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 129 patients will be accrued for this study within 6 months
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-2012-03147 | REGISTRY | None | None |
| U10CA021115 | NIH | None | None |
| CDR0000368459 | None | None | None |
| ECOG-E3503 | None | None | None |
| E3503 | OTHER | None | None |
| E3503 | OTHER | CTEP | httpsreporternihgovquickSearchU10CA021115 |