Clinical Trial: NCT01707823 - My Cancer Genome

NCT01707823

Description:

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

Related Conditions:

Non-Small Cell Lung Carcinoma

Recruiting Status:

Terminated

Phase:

Early Phase 1

URL:

https://clinicaltrials.gov/show/NCT01707823

Trial Eligibility

Document

Title

Brief Title: Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer
Official Title: Prevention of Death From Adenocarcinoma of the Lung by Low Dose Aspirin

Clinical Trial IDs

ORG STUDY ID: VICC THN 1227
SECONDARY ID: NCI-2012-01800
SECONDARY ID: P50CA090949
NCT ID: NCT01707823

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

Drug	Synonyms	Arms
acetylsalicylic acid	ASA, Ecotrin, Empirin, Extren	Prevention (acetylsalicylic acid)

Purpose

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.

Trial Arms

Name	Type	Description	Interventions
Prevention (acetylsalicylic acid)	Experimental	Patients receive acetylsalicylic acid PO for 7 days.	acetylsalicylic acid

Eligibility Criteria

        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

Maximum Eligible Age:	N/A
Minimum Eligible Age:	18 Years
Eligible Gender:	All
Healthy Volunteers:	No

Primary Outcome Measures

Measure:	Change in PGE2 biosynthesis from baseline and at 14 days after discontinuation of a 7-day course of 325 mg ASA per day
Time Frame:	14 days
Safety Issue:
Description:	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.

Secondary Outcome Measures

Measure:	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
Time Frame:	14 days
Safety Issue:
Description:	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.

Details

Phase:	Early Phase 1
Primary Purpose:	Interventional
Overall Status:	Terminated
Lead Sponsor:	Vanderbilt-Ingram Cancer Center

Last Updated

January 14, 2020

Clinical Trials /

Low-Dose Acetylsalicylic Acid in Treating Patients With Stage I-III Non-Small Cell Lung Cancer