Ignite Creation Date:
2024-05-05 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 9:40 AM
Study NCT ID:
NCT00588445
Status:
COMPLETED
Last Update Posted:
2016-01-22
First Post:
2007-12-26
Brief Title:
Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial to Correlate Radiographic Response Induced By Gefitinib With Mutations in the Protein-Tyrosine Kinase Domain of the EGF Receptor Gene in Patients With NSCLC
Status:
COMPLETED
Status Verified Date:
2015-12
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:
The purpose of this research study is to
see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery
see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene
see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene
see if the pattern of protein expression in the blood is related to the tumors sensitivity or resistance to gefitinib treatment
see if expression of certain genes in the tumor are related to the tumors sensitivity or resistance to gefitinib treatment
see if gefitinib pills can shrink Stage 1 or 2 non-small cell lung cancers before surgery
see if your non-small cell lung cancer has a mutation in a certain part of the EGFR gene
see if patients whose tumor does shrink with gefitinib treatment are more likely to have a mutation in a certain part of the EGFR gene
see if the pattern of protein expression in the blood is related to the tumors sensitivity or resistance to gefitinib treatment
see if expression of certain genes in the tumor are related to the tumors sensitivity or resistance to gefitinib treatment
Detailed Description:
This is a phase II single institution trial to correlate gefitinib response and mutations in the protein-tyrosine kinase domain of the EGF receptor gene The study will be conducted in patients with Stage I and II NSCLC who have been determined to be operable and resectable
Patients must have 1 or more of the following features never smoker or smoking history of 15 pack years andor features of bronchioloalveolar lung cancer 50 patients will be enrolled on this study Treatment will be with gefitinib for at least 21 days before surgery depending on the timing of the surgery Patients will discontinue gefitinib 2 days before their operation For patients that demonstrate a radiographic response to gefitinib preoperatively and or patients with mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified from the surgical sample gefitinib will continue for 2 years post-surgery Patients who do not have evidence of radiographic response or mutations in the protein-tyrosine kinase domain of the EGF receptor gene will be removed from the study
Patients must have 1 or more of the following features never smoker or smoking history of 15 pack years andor features of bronchioloalveolar lung cancer 50 patients will be enrolled on this study Treatment will be with gefitinib for at least 21 days before surgery depending on the timing of the surgery Patients will discontinue gefitinib 2 days before their operation For patients that demonstrate a radiographic response to gefitinib preoperatively and or patients with mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified from the surgical sample gefitinib will continue for 2 years post-surgery Patients who do not have evidence of radiographic response or mutations in the protein-tyrosine kinase domain of the EGF receptor gene will be removed from the study
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 |
|---|---|---|---|
| CA113653 | None | None | None |