Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer

PRIMARY OBJECTIVES:

I. To determine whether ASA (acetylsalicylic acid) 325 mg inhibits prostaglandin E2 (PGE2)
biosynthesis in patients with early stage non-small cell lung cancer (NSCLC). Cyclooxygenase
(COX) catalytic activity will be determined by measuring the metabolite of PGE2,
11alpha-hydroxy-9,12-dioxo-2,3,4,5-tetranor-prostane-1,20 dioic acid (PGE-M) in urine pre-
and post-ASA 325 mg as a surrogate of systemic PGE2 biosynthesis.

SECONDARY OBJECTIVES:

I. To determine whether COX-2 protein has a slow turnover in adenocarcinoma of the lung. COX
turnover will be determined by measuring urinary PGE-M levels daily for 7 days after
discontinuing ASA 325 mg. COX-2 and Prostaglandin expression will also be measured in tumor
samples of patients taken at the time of surgery.

OUTLINE:

Patients receive acetylsalicylic acid orally (PO) for 7 days and urine is collected for 7
days post therapy.

Inclusion Criteria:

- Have confirmed (stage IIIb-IV) or recurrent non-small cell lung cancer, adenocarcinoma
histology

- Understand and voluntarily sign an informed consent document prior to any study
related assessments or procedures are conducted

- Anticipated that they will complete all study procedures

- Ability to swallow pills

- No aspirin in the last 7 days

Exclusion Criteria:

- Know allergy to aspirin or other nonsteroidal anti-inflammatory drugs

- History of allergic reaction to aspirin or other non-steroidal anti-inflammatory
drugs, including ibuprofen

- Any other concomitant serious illness or organ system dysfunction which in the opinion
of the investigator would either compromise patient safety