COX-2 Activity in Early and Advanced NSCLC and The Effect of Short-Term Administration of Specific COX-2 Inhibitors (Celecoxib)
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.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Correlation of expression of cyclo-oxygenase-2 (COX-2) activity with serum VEGF levels, tumor microvessel density score, tumor PEG2 and MMP levels, and urinary PGE-M
COX-2 will be measured in pre-treatment tumor biopsy tissue as well as tumor microvessel density, MMP-2 and PGE2. VEGF will be measured in pre-treatment blood.
Date of pretreatment biopsy surgery (tissue) and day 1 (blood)
No
Vicki Keedy, MD
Principal Investigator
Vanderbilt-Ingram Cancer Center
United States: Federal Government
VICC THO 0055
NCT00653250
December 2000
January 2008
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