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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
3 other identifiers
interventional
4
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for early_phase_1
Started Oct 2012
Longer than P75 for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 12, 2012
CompletedFirst Posted
Study publicly available on registry
October 16, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedJanuary 14, 2020
January 1, 2020
5.7 years
October 12, 2012
January 10, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change in PGE2 biosynthesis from baseline and at 14 days after discontinuation of a 7-day course of 325 mg ASA per day
PGE2 is a product of the COX-2 protein. Measurement of its urinary metabolite PGE-M would indicate the level of systemic biosynthesis of PGE2 and thus inhibition of COX-2 product formation.
14 days
Secondary Outcomes (1)
Change in PGE-M levels from baseline and daily for 7 days after discontinuation of a 7-day course of 325 mg ASA per day
14 days
Study Arms (1)
Prevention (acetylsalicylic acid)
EXPERIMENTALPatients receive acetylsalicylic acid PO for 7 days.
Interventions
Given PO
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leora Horn
Vanderbilt-Ingram Cancer Center
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist
Study Record Dates
First Submitted
October 12, 2012
First Posted
October 16, 2012
Study Start
October 1, 2012
Primary Completion
June 1, 2018
Study Completion
August 1, 2018
Last Updated
January 14, 2020
Record last verified: 2020-01