Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer
Conditions
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
Conditions: official terms
Adenocarcinoma - Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Intervention
Name: acetylsalicylic acid Type: Drug
Name: laboratory biomarker analysis Type: Other
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: N/A
Gender: Both
Criteria: 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

Exclusion Criteria:

- 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
Location
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Status: Recruiting
Contact: Leora Horn - 615-322-2918
Start Date
October 2012
Completion Date
December 2018
Sponsors
Vanderbilt-Ingram Cancer Center
Source
Vanderbilt-Ingram Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page