Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00063258
Status:
TERMINATED
Last Update Posted:
2016-05-09
First Post:
2003-06-24
Brief Title:
Tarceva Surgery for Resectable Stage IIIAN2 and IIIB T4 N2 Non-Small-Cell Lung Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Randomized Open-Label Trial of the EGFR Tyrosine Kinase Inhibitor OSI-774 Tarceva in Combination With Paclitaxel and Carboplatin Prior to Surgery in Resectable Stage IIIA N2 and IIIB T4 N2 NSCLC A Clinical Outcome and Biological Endpoint Trial
Status:
TERMINATED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual rate
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical research study is to learn about the safety and effectiveness of OSI-774 when combined with standard chemotherapy carboplatin and paclitaxel before surgery in the treatment of non-small cell lung cancer
Detailed Description:
This is a phase II single institution open label randomized trial of induction carboplatin and paclitaxel plusminus daily oral OSI-774 in patients with potentially resectable NSCLC that is stage IIIA and IIIB T4 satellite nodules or invasion into T4 structures but no malignant effusion N3 disease is excluded Patients will be required to have pathologically demonstrated N2 disease via mediastinoscopy Forty patients will be treated with 3 courses of chemotherapy followed by surgery Ten of these patients will be randomized to chemotherapy alone and 30 patients to chemotherapy plus OSI-774 The 10 patients will serve as a chemotherapy alone control for molecular endpoint analysis OSI-774 will be stopped the night before surgery At the time of surgery pathologic response will be determined Following surgery patients will be treated with consolidation radiation therapy if there are positive margins or N2 lymph nodes at the time of resection Patients who have no N2 disease at surgery will have the option of consolidation radiation therapy but will not be required to have it done Patients not able to tolerate radiation even if they have N2 disease or positive margins at surgery may continue on this study This will be followed by maintenance OSI-774 for patients from both arms of the study OSI-774 will be continued as maintenance to a maximum of 2 years following surgery Tissue for molecular studies will be obtained pretreatment either at the time of diagnostic biopsy or mediastinoscopy Post-treatment tissue will be obtained at the time of surgery This tissue will be assayed for defined molecular endpoints using immunohistochemistry immunoprecipitation and mRNA expression analysis Blood urine hair follicles and skin samples will also be collected from patients who consent to provide these
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