Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer
Purpose
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
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Early Phase 1
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Basic Science
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Prevention (acetylsalicylic acid) |
Patients receive acetylsalicylic acid PO for 7 days. |
|
More Details
- Status
- Terminated
- Sponsor
- Vanderbilt-Ingram Cancer Center
Study Contact
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.