Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer
Adenocarcinoma of the Lung
Recurrent Non-small Cell Lung Cancer
Stage IA Non-small Cell Lung Cancer
Stage IB Non-small Cell Lung Cancer
Stage IIA Non-small Cell Lung Cancer
Stage IIB Non-small Cell Lung Cancer
Stage IIIA Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Drug: acetylsalicylic acid
Other: laboratory biomarker analysis
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
|Official Title:||Prevention of Death From Adenocarcinoma of the Lung by Low Dose Aspirin|
- Change in PGE2 biosynthesis from baseline and at 14 days after discontinuation of a 7-day course of 325 mg ASA per day [ Time Frame: 14 days ] [ Designated as safety issue: No ]PGE2 is a product of the COX-2 protein. Measurement of its urinary metabolite PGE-M would indicate the level of systemic biosynthesis of PGE2 and thus inhibition of COX-2 product formation.
- Change in PGE-M levels from baseline and daily for 7 days after discontinuation of a 7-day course of 325 mg ASA per day [ Time Frame: 14 days ] [ Designated as safety issue: No ]PGE-M is a metabolite of PGE2 in urine. PGE2 is a product of the COX-2 protein. Evidence suggests that COX-2 and PGE2 participate in tumor growth, apoptosis and metastasis, angiogenesis and abrogation of the tumor response. ASA inhibits COX-2. A slow rate of recovery in urinary levels of urinary PGE-M would indicate the rate of catalytically active COX-2 after discontinuation of ASA and may explain the efficacy of once daily low-dose ASA.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||December 2018|
|Estimated Primary Completion Date:||September 2018 (Final data collection date for primary outcome measure)|
Experimental: Prevention (acetylsalicylic acid)
Patients receive acetylsalicylic acid PO for 7 days.
Drug: acetylsalicylic acid
Other Names:Other: laboratory biomarker analysis
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01707823
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Leora Horn||Vanderbilt-Ingram Cancer Center|