Celecoxib in Treating Patients With Stage I, Stage II, or Stage IIIA Non-Small Cell Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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COX-2 Activity in Early and Advanced NSCLC and The Effect of Short-Term Administration of Specific COX-2 Inhibitors (Celecoxib)

Conditions
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Lung Cancer

Intervention / Treatment
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* Drug: celecoxib
* Procedure: biopsy
* Procedure: therapeutic conventional surgery


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Presumed histological or cytological diagnosis of non-small cell lung cancer Diagnosis to be confirmed upon study entry to collect biopsy material for correlative studies Stage I-IIIA disease PATIENT CHARACTERISTICS: ECOG performance status of 0-2 Serum creatinine ≤ 1.5 mg/dL Granulocytes ≥ 1,500/mm^3 Platelets ≥ 100,000/mm^3 AST ≤ 3 times normal Bilirubin ≤ 1.5 mg/dL Not pregnant or nursing Fertile patients must use effective contraception No active unresolved infection PRIOR CONCURRENT THERAPY: At least 7 days since prior and no concurrent non-steroidal anti-inflammatory agents or other cyclo-oxygenase-2 inhibitors At least 7 days since prior parenteral antibiotics No prior systemic chemotherapy or radiotherapy
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Therapeutic Intervention<br>Correlative | Drug: celecoxib<br>* 400 mg P.O. BID for five days prior to obtaining second serum/urine collection (starting after initial biopsy, serum and urine collection)<br>* Other names: celebrex;Procedure: biopsy<br>* in patients with newly diagnosed NSCLC, a pretreatment excision of a small amount of tumor tissue<br>Procedure: therapeutic conventional surgery<br>* surgery to remove the lung tumor<br>* Other names: tumor resection;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of Celecoxib on COX-2 expression and microvascular density in tumor, PGE2 and MMP levels in tumor, serum VEGF levels and urinary PGE-M | Patients with early-stage NSCLC will undergo tumor resection after 5 days of treatment with celecoxib. Tumor tissue will be examined. Post-treatment blood and urine will also be collected and examined. | After day 5 of 5 days of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I non-small cell lung cancer, stage II non-small cell lung cancer, stage IIIA non-small cell lung cancer