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Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer

This study is currently recruiting participants.
Verified June 2017 by Leora Horn, MD, Vanderbilt-Ingram Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01707823
First Posted: October 16, 2012
Last Update Posted: July 2, 2017
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.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Leora Horn, MD, Vanderbilt-Ingram Cancer Center
October 12, 2012
October 16, 2012
July 2, 2017
October 2012
September 2018   (Final data collection date for primary outcome measure)
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.
  • Inhibition of PGE2 biosynthesis [ Time Frame: 14 days ]
    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 ]
    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.
Complete list of historical versions of study NCT01707823 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
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Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer
Prevention of Death From Adenocarcinoma of the Lung by Low Dose Aspirin
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

PRIMARY OBJECTIVES:

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.

SECONDARY OBJECTIVES:

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.

OUTLINE:

Patients receive acetylsalicylic acid orally (PO) for 7 days and urine is collected for 7 days post therapy.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
  • 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
    Given PO
    Other Names:
    • ASA
    • Ecotrin
    • Empirin
    • Extren
  • Other: laboratory biomarker analysis
    Correlative studies
Experimental: Prevention (acetylsalicylic acid)
Patients receive acetylsalicylic acid PO for 7 days.
Interventions:
  • Drug: acetylsalicylic acid
  • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2018
September 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have confirmed (stage IIIb-IV) or recurrent non-small cell lung cancer, adenocarcinoma histology
  • Understand and voluntarily sign an informed consent document prior to any study related assessments or procedures are conducted
  • Anticipated that they will complete all study procedures
  • Ability to swallow pills
  • No aspirin in the last 7 days

Exclusion Criteria:

  • Know allergy to aspirin or other nonsteroidal anti-inflammatory drugs
  • History of allergic reaction to aspirin or other non-steroidal anti-inflammatory drugs, including ibuprofen
  • Any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise patient safety
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: VICC Clinical Trials Information Program 800-811-8480
United States
 
 
NCT01707823
VICC THN 1227
NCI-2012-01800 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P50CA090949 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Not Provided
Leora Horn, MD, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Leora Horn Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP