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


N/A
N/A
N/A
Open (Enrolling)
Both
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Inhibition of PGE2 biosynthesis

Outcome Description:

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.

Outcome Time Frame:

14 days

Safety Issue:

No

Principal Investigator

Leora Horn

Investigator Role:

Principal Investigator

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC THN 1227

NCT ID:

NCT01707823

Start Date:

October 2012

Completion Date:

December 2018

Related Keywords:

  • 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
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838