Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
| Condition | Intervention |
|---|---|
|
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 |
Drug: acetylsalicylic acid Other: laboratory biomarker analysis |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Basic Science |
| Official Title: | Prevention of Death From Adenocarcinoma of the Lung by Low Dose Aspirin |
- Inhibition of PGE2 biosynthesis [ Time Frame: 14 days ] [ Designated as safety issue: No ]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.
- Urinary PGE-M levels [ Time Frame: 14 days ] [ Designated as safety issue: No ]Descriptive statistics, including means, standard deviations, and ranges will be provided. Before-after treatment differences of PGE-M level will be examined using paired t-test or Wilcoxon matched-pair test. 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.
| Estimated Enrollment: | 40 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | December 2018 |
| Estimated Primary Completion Date: | September 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Prevention (acetylsalicylic acid)
Patients receive acetylsalicylic acid PO for 7 days.
|
Drug: acetylsalicylic acid
Given PO
Other Names:
Other: laboratory biomarker analysis
Correlative studies
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center | Recruiting |
| Nashville, Tennessee, United States, 37232-6838 | |
| Contact: Leora Horn 615-322-2918 | |
| Principal Investigator: Leora Horn | |
| Principal Investigator: | Leora Horn | Vanderbilt-Ingram Cancer Center |
More Information
No publications provided
| Responsible Party: | Leora Horn, MD, Assistant Professor of Medicine; Assistant Director, Educator Development Program; Clinical Director, Thoracic Oncology Program; Medical Oncologist, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT01707823 History of Changes |
| Other Study ID Numbers: | VICC THN 1227, NCI-2012-01800, P50CA090949 |
| Study First Received: | October 12, 2012 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United States: Federal Government |
Additional relevant MeSH terms:
|
Carcinoma, Non-Small-Cell Lung Adenocarcinoma Adenocarcinoma, Mucinous Lung Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases |
Respiratory Tract Diseases Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 19, 2013