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

This study is currently recruiting participants.

Verified November 2012 by Vanderbilt-Ingram Cancer Center

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

Leora Horn, MD, Vanderbilt-Ingram Cancer Center

ClinicalTrials.gov Identifier:

NCT01707823

First received: October 12, 2012

Last updated: November 28, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 12, 2012

Last Updated Date

November 28, 2012

Start Date ^ICMJE

October 2012

Estimated Primary Completion Date

September 2018 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01707823 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Prevention of Death From Adenocarcinoma of the Lung by Low Dose Aspirin

Brief Summary

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

Detailed Description

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: acetylsalicylic acid
Given PO
Other Names:
- ASA
- Ecotrin
- Empirin
- Extren
Other: laboratory biomarker analysis
Correlative studies

Study Arm (s)

Experimental: Prevention (acetylsalicylic acid)

Patients receive acetylsalicylic acid PO for 7 days.

Interventions:

Drug: acetylsalicylic acid
Other: laboratory biomarker analysis

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2018

Estimated Primary Completion Date

September 2018 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

All patients with early stage (stage I-III) non-small cell lung cancer, adenocarcinoma histology
Patients who are seen by members of the Thoracic Surgical oncology Group at Vanderbilt Ingram Cancer Center for their initial surgical consultation
Patients who have taken ASA or nonsteroidal anti-inflammatory drugs (NSAIDs) in the last two weeks or have an allergy to ASA will not be eligible for enrollment

Gender

Both

Ages

Not Provided

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01707823

Other Study ID Numbers ^ICMJE

VICC THN 1227, NCI-2012-01800, P50CA090949

Has Data Monitoring Committee

Yes

Responsible Party

Leora Horn, MD, Vanderbilt-Ingram Cancer Center

Study Sponsor ^ICMJE

Vanderbilt-Ingram Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Leora Horn

Vanderbilt-Ingram Cancer Center

Information Provided By

Vanderbilt-Ingram Cancer Center

Verification Date

November 2012

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

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