Prevention of Death From Adenocarcinoma of the Lung by Low Dose Aspirin
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.
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.
Patients receive acetylsalicylic acid orally (PO) for 7 days and urine is collected for 7
days post therapy.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Inhibition of PGE2 biosynthesis
Pearson chi-square test or Fisher's exact test will be used to assess the categorical variables. Hypotheses will be tested at the level of alpha = 0.05. Point estimates along with the corresponding p-values and 95% confidence intervals will be reported.
Vanderbilt-Ingram Cancer Center
United States: Federal Government
VICC THN 1227
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|