NCT01707823

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

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	acetylsalicylic acid	Given PO
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2012-10-01
• Primary completion: 2018-06-01
• Completion: 2018-08-01
• First posted: 2012-10-16
• Last updated: 2020-01-14

Locations

1 site across 1 country: United States