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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-01800 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P50CA090949 | U.S. NIH Grant/Contract | View source |
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Funding unavailable
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prevention (acetylsalicylic acid) | Experimental | Patients receive acetylsalicylic acid PO for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| acetylsalicylic acid | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | PGE-M is a metabolite of PGE2 in urine. PGE2 is a product of the COX-2 protein. Evidence suggests that COX-2 and PGE2 participate in tumor growth, apoptosis and metastasis, angiogenesis and abrogation of the tumor response. ASA inhibits COX-2. A slow rate of recovery in urinary levels of urinary PGE-M would indicate the rate of catalytically active COX-2 after discontinuation of ASA and may explain the efficacy of once daily low-dose ASA. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leora Horn | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232-6838 | United States |
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| Label | URL |
|---|---|
| Vanderbilt-Ingram Cancer Center, Find a Clinical Trial | View source |
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| laboratory biomarker analysis | Other | Correlative studies |
|
| 14 days |
| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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