Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01707823|
Recruitment Status : Recruiting
First Posted : October 16, 2012
Last Update Posted : July 2, 2017
|Condition or disease||Intervention/treatment|
|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|
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 Names: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|