Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-27 @ 1:54 AM
Study NCT ID:
NCT00653250
Status:
COMPLETED
Last Update Posted:
2013-05-21
First Post:
2008-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celecoxib in Treating Patients With Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
COX-2 Activity in Early and Advanced NSCLC and The Effect of Short-Term Administration of Specific COX-2 Inhibitors (Celecoxib)
Status:
COMPLETED
Status Verified Date:
2013-05
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:
RATIONALE: Studying samples of tissue, blood, and urine from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This clinical trial is studying celecoxib in treating patients with stage I, stage II, or stage IIIA non-small cell lung cancer.
PURPOSE: This clinical trial is studying celecoxib in treating patients with stage I, stage II, or stage IIIA non-small cell lung cancer.
Detailed Description:
OBJECTIVES:
* To assess cyclo-oxygenase-2 (COX-2) activity in patients with early-stage non-small cell lung cancer (NSCLC) and correlate the results with serum vascular endothelial growth factor (VEGF) levels, tumor microvessel density score, tumor prostaglandin E2 (PGE\_2) and matrix metalloproteinases (MMP) levels, and the major urinary metabolite of PGE\_2, PGE-M.
* To assess the effect of specific COX-2 inhibitors (celecoxib) on COX-2 expression within the primary tumor, serum VEGF levels and tumor microvascular density, tumor PGE\_2 and MMP levels, and urinary PGE-M in a cohort of patients with early-stage NSCLC.
OUTLINE: Patients receive oral celecoxib 400 mg twice a day for 5 days in the absence of disease progression or unaccepted toxicity. Patients with early-stage disease then undergo surgery.
Biopsy, serum, and urine samples are obtained at baseline and after celecoxib treatment. The biopsy specimen are examined for the expression of cyclo-oxygenase-2 (COX-2), PGE\_2, and selected MMPs by immunohistochemistry, western blotting, and northern blotting. Serum and urine samples are analyzed for VEGF and PGE-M expression. COX-2 tumor expression is correlated with serum VEGF levels; tumor MMP-2, MMP-9, and PGE\_2 expression; urinary PGE-M and microvessel density scores.
* To assess cyclo-oxygenase-2 (COX-2) activity in patients with early-stage non-small cell lung cancer (NSCLC) and correlate the results with serum vascular endothelial growth factor (VEGF) levels, tumor microvessel density score, tumor prostaglandin E2 (PGE\_2) and matrix metalloproteinases (MMP) levels, and the major urinary metabolite of PGE\_2, PGE-M.
* To assess the effect of specific COX-2 inhibitors (celecoxib) on COX-2 expression within the primary tumor, serum VEGF levels and tumor microvascular density, tumor PGE\_2 and MMP levels, and urinary PGE-M in a cohort of patients with early-stage NSCLC.
OUTLINE: Patients receive oral celecoxib 400 mg twice a day for 5 days in the absence of disease progression or unaccepted toxicity. Patients with early-stage disease then undergo surgery.
Biopsy, serum, and urine samples are obtained at baseline and after celecoxib treatment. The biopsy specimen are examined for the expression of cyclo-oxygenase-2 (COX-2), PGE\_2, and selected MMPs by immunohistochemistry, western blotting, and northern blotting. Serum and urine samples are analyzed for VEGF and PGE-M expression. COX-2 tumor expression is correlated with serum VEGF levels; tumor MMP-2, MMP-9, and PGE\_2 expression; urinary PGE-M and microvessel density scores.
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| P50CA090949 | NIH | None | https://reporter.nih.gov/quic… | View |
| P30CA068485 | NIH | None | https://reporter.nih.gov/quic… | View |
| VU-VICC-THO-0055 | None | None | View | |
| VU-VICC-000724 | None | None | View |