Ignite Creation Date:
2024-05-05 @ 11:35 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00087269
Status:
TERMINATED
Last Update Posted:
2013-06-06
First Post:
2004-07-08
Brief Title:
Erlotinib in Treating Patients With Stage I-IIIA Non-Small Cell Lung Cancer Undergoing Surgical Resection
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study to Evaluate the Tumor Biochemical Effects of the EGFR Tyrosine Kinase Inhibitor OSI-774 Erlotinib Administered Prior to Surgical Resection in Patients With Early Stage Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2013-06
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 stage I stage II or stage IIIA non-small cell lung cancer Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth Giving erlotinib before surgery may shrink the tumor so that it can be removed
Detailed Description:
PRIMARY OBJECTIVES
I To determine the biochemical response rate 75 decrease in P-MAPK andor P-AKT with daily oral OSI-774 erlotinib for 14 consecutive days in patients with early stage operable NSCLC
SECONDARY OBJECTIVES
I To evaluate the safety and tolerance of daily oral OSI-774 erlotinib as pre-operative treatment for early stage operable NSCLC
TERTIARY OBJECTIVES
I To correlate antiproliferative Ki-67 p27 and apoptotic TUNEL assay tumor responses to OSI-774 erlotinib with pre-therapy tumor and skin EGFR pathway functional status and post-therapy tumor and skin EGFR pathway inhibition in patients with resectable NSCLC treated preoperatively with OSI-774 erlotinib for 14 days
II Assessment of functional EGFR status HER1 HER-2 HER3 HER4 PHER1 AKT P-AKT MAPK-P-MAPK STAT-3 P-STAT-3 EGFR-III by immunohistochemistry IHC
III Assessment of proliferative response Ki67 and p27 by IHC IV Assessment of apoptotic response TUNEL assay V To study the role of the gastrin-releasing factor and estrogen receptor pathways in the sensitivity and resistance of NSCLC to OSI-774 erlotinib
VI To identify patterns of gene and protein expression pre-therapy and post-therapy that are associated with tumor clinical biochemical antiproliferative and apoptotic responses
VII To study the antitumor activity of OSI-774 erlotinib in NSCLC tumors heterotransplanted in nude mice after surgical resection and to investigate the sequential molecular changes associated with tumor response to OSI-774 erlotinib therapy
OUTLINE This is a multicenter study
Patients receive oral erlotinib once daily on days 1-14 or days 1-21 in the absence of unacceptable toxicity Patients then undergo surgical resection on the last day of study drug administration day 14 or day 21 Patients may receive chemotherapy andor radiotherapy after surgical resection at the discretion of the primary physician
Patients are followed for 5 years after study registration
I To determine the biochemical response rate 75 decrease in P-MAPK andor P-AKT with daily oral OSI-774 erlotinib for 14 consecutive days in patients with early stage operable NSCLC
SECONDARY OBJECTIVES
I To evaluate the safety and tolerance of daily oral OSI-774 erlotinib as pre-operative treatment for early stage operable NSCLC
TERTIARY OBJECTIVES
I To correlate antiproliferative Ki-67 p27 and apoptotic TUNEL assay tumor responses to OSI-774 erlotinib with pre-therapy tumor and skin EGFR pathway functional status and post-therapy tumor and skin EGFR pathway inhibition in patients with resectable NSCLC treated preoperatively with OSI-774 erlotinib for 14 days
II Assessment of functional EGFR status HER1 HER-2 HER3 HER4 PHER1 AKT P-AKT MAPK-P-MAPK STAT-3 P-STAT-3 EGFR-III by immunohistochemistry IHC
III Assessment of proliferative response Ki67 and p27 by IHC IV Assessment of apoptotic response TUNEL assay V To study the role of the gastrin-releasing factor and estrogen receptor pathways in the sensitivity and resistance of NSCLC to OSI-774 erlotinib
VI To identify patterns of gene and protein expression pre-therapy and post-therapy that are associated with tumor clinical biochemical antiproliferative and apoptotic responses
VII To study the antitumor activity of OSI-774 erlotinib in NSCLC tumors heterotransplanted in nude mice after surgical resection and to investigate the sequential molecular changes associated with tumor response to OSI-774 erlotinib therapy
OUTLINE This is a multicenter study
Patients receive oral erlotinib once daily on days 1-14 or days 1-21 in the absence of unacceptable toxicity Patients then undergo surgical resection on the last day of study drug administration day 14 or day 21 Patients may receive chemotherapy andor radiotherapy after surgical resection at the discretion of the primary physician
Patients are followed for 5 years after study registration
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 |
|---|---|---|---|
| U10CA021115 | NIH | None | httpsreporternihgovquickSearchU10CA021115 |
| E4503 | None | None | None |