Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00385996
Status:
COMPLETED
Last Update Posted:
2018-12-28
First Post:
2006-10-09
Brief Title:
Pilot Study of Preoperative Tarceva Erlotinib for Stages III Non-Small Cell Lung Cancer
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
A Pilot Study of Preoperative Tarceva Erlotinib Monotherapy in Patients With Early Stage III Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2018-12
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 main purpose of this study is to see if Tarceva erlotinib is effective in shrinking tumors A high resolution CT scan CT scanner that can view 3 dimensional images of the tumor will be used to measure the tumor before and after treatment with Tarcevaerlotinib This type of CT scan will measure the tumor by volume and by standard measurement length and width Both methods will be compared to find out whether standard measurement or measurement by tumor volume is more accurate
Detailed Description:
Tarceva erlotinib is a drug that blocks a receptor called the Epidermal Growth Factor Receptor EGFR on certain cells including tumor cells Blocking this receptor has been shown to shrink tumors in some patients Tarcevaerlotinib is approved for commercial use by the US Food and Drug Administration for treatment of Non-Small Cell Lung Cancer NSCLC after failure of at least one chemotherapy treatment However it is not approved for the first treatment of Non-Small Cell Lung Cancer NSCLC which is the treatment used in this study
Patients with early stage non-small cell lung cancer will receive daily Tarceva erlotinib at 150 mgday for 3 weeks followed by surgical resection at week 4 High resolution CT scans for tumor response assessment will be obtained at baseline and after 3 weeks of treatment with Tarceva erlotinib Post-operative 2-year treatment with Tarceva erlotinib will be offered to patients who had at least a 50 half decrease in size of their tumor after treatment with Tarceva erlotinibandor patients with tumors that were found to have the receptor Epidermal Growth Factor Receptor EGFR on their tumor cells at the time of their surgery
Post-operative chemotherapy will be administered at the discretion of the treating physician to patients with stages IB and II Patients who receive post-operative chemotherapy will begin Tarceva erlotinibno sooner than 3 weeks from Day 1 of the last chemotherapy cycle and no longer than 6 months after surgery Follow-up for recurrence and survival will continue for 2 years
Patients with early stage non-small cell lung cancer will receive daily Tarceva erlotinib at 150 mgday for 3 weeks followed by surgical resection at week 4 High resolution CT scans for tumor response assessment will be obtained at baseline and after 3 weeks of treatment with Tarceva erlotinib Post-operative 2-year treatment with Tarceva erlotinib will be offered to patients who had at least a 50 half decrease in size of their tumor after treatment with Tarceva erlotinibandor patients with tumors that were found to have the receptor Epidermal Growth Factor Receptor EGFR on their tumor cells at the time of their surgery
Post-operative chemotherapy will be administered at the discretion of the treating physician to patients with stages IB and II Patients who receive post-operative chemotherapy will begin Tarceva erlotinibno sooner than 3 weeks from Day 1 of the last chemotherapy cycle and no longer than 6 months after surgery Follow-up for recurrence and survival will continue 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