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

Vanderbilt University Medical Center

Status and phase

Terminated

Early Phase 1

Conditions

Stage IIB Non-small Cell Lung Cancer

Stage IIIB Non-small Cell Lung Cancer

Stage IB Non-small Cell Lung Cancer

Stage IIA Non-small Cell Lung Cancer

Stage IA Non-small Cell Lung Cancer

Adenocarcinoma of the Lung

Stage IIIA Non-small Cell Lung Cancer

Recurrent Non-small Cell Lung Cancer

Treatments

Other: laboratory biomarker analysis

Drug: acetylsalicylic acid

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01707823

VICC THN 1227

P50CA090949 (U.S. NIH Grant/Contract)

NCI-2012-01800 (Registry Identifier)

Details and patient eligibility

About

This pilot clinical trial studies low-dose acetylsalicylic acid in treating patients with stage I-III non-small cell lung cancer. Studying samples of urine and blood from patients with cancer in the laboratory may help doctors learn more about changes in biomarkers that occur during treatment with acetylsalicylic acid

Full description

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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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