Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer
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
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|
- Inhibition of PGE2 biosynthesis [ Time Frame: 14 days ] [ Designated as safety issue: No ]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.
- Urinary PGE-M levels [ Time Frame: 14 days ] [ Designated as safety issue: No ]Descriptive statistics, including means, standard deviations, and ranges will be provided. Before-after treatment differences of PGE-M level will be examined using paired t-test or Wilcoxon matched-pair test. 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.
|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.
|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|