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

Vanderbilt University Medical Center

Status

Completed

Conditions

Lung Cancer

Treatments

Procedure: therapeutic conventional surgery

Drug: celecoxib

Procedure: biopsy

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00653250

VU-VICC-THO-0055

P30CA068485 (U.S. NIH Grant/Contract)

P50CA090949 (U.S. NIH Grant/Contract)

VICC THO 0055

VU-VICC-000724

Details and patient eligibility

About

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.

Full 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.

Enrollment

22 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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