Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT01707823|
Recruitment Status : Recruiting
First Posted : October 16, 2012
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|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||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Prevention of Death From Adenocarcinoma of the Lung by Low Dose Aspirin|
|Study Start Date :||October 2012|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Prevention (acetylsalicylic acid)
Patients receive acetylsalicylic acid PO for 7 days.
Drug: acetylsalicylic acid
Other: laboratory biomarker analysis
- 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 ]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 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01707823
|Contact: VICC Clinical Trials Information Program||800-811-8480|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232-6838|
|Contact: Leora Horn 615-322-2918|
|Principal Investigator: Leora Horn|
|Principal Investigator:||Leora Horn||Vanderbilt-Ingram Cancer Center|