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Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00468910
First received: May 2, 2007
Last updated: December 6, 2013
Last verified: December 2013

May 2, 2007
December 6, 2013
March 2007
December 2009   (final data collection date for primary outcome measure)
  • Change in spectral slope [ Time Frame: From baseline to 3 months after completion of study treatment ] [ Designated as safety issue: No ]
    The difference in the observed change from baseline in each arm, aspirin and placebo, will be compared.
  • Change in fractal dimension [ Time Frame: From baseline to 3 months after completion of study treatment ] [ Designated as safety issue: No ]
    The difference in the observed change from baseline in each arm, aspirin and placebo, will be compared.
  • Observed change from baseline in spectral slope and fractal dimension
  • Reversal of neoplastic micro-architectural changes as assessed by 4D-ELF parameters by aspirin
Complete list of historical versions of study NCT00468910 on ClinicalTrials.gov Archive Site
  • Colonic epithelial apoptosis as measured by immunohistochemical detection of cleaved caspase 3 [ Time Frame: Up to 3 months after completion of study treatment ] [ Designated as safety issue: No ]
  • Colonic cell proliferation as measured by immunohistochemical detection of Ki67 [ Time Frame: Up to 3 months after completion of study treatment ] [ Designated as safety issue: No ]
  • Rectal prostaglandin levels as measured by ELISA [ Time Frame: Up to 3 months after completion of study treatment ] [ Designated as safety issue: No ]
  • Platelet cyclooxygenase (COX) activity as measured by a peroxidase-based COX enzyme activity assay [ Time Frame: Up to 3 months after completion of study treatment ] [ Designated as safety issue: No ]
  • Colonic epithelial apoptosis and cell proliferation as measured by immunohistochemical detection of cleaved caspase 3 and Ki-67 expression
  • Rectal prostaglandin levels as measured by ELISA
  • Platelet cyclooxygenase (COX) activity as measured by a peroxidase-based COX enzyme activity assay
  • Correlation of spectral marker alterations with UGT1A6 genotype
  • Rectal prostaglandin levels
  • Rectal apoptosis
  • Rectal proliferation
Not Provided
Not Provided
 
Aspirin in Preventing Colorectal Cancer in Patients at Increased Risk of Colorectal Cancer
Spectral Markers in Aspirin Chemoprevention of Colonic Neoplasia

This randomized phase II trial is studying how well aspirin works in preventing colorectal cancer in patients at increased risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of aspirin may prevent colorectal cancer.

PRIMARY OBJECTIVE:

I. Determine whether acetylsalicylic acid (aspirin) will alter spectral markers (i.e., spectral slope and fractal dimension) in distal colonic mucosa of patients who are at increased risk for the development or recurrence of colorectal cancer.

SECONDARY OBJECTIVES:

I. Assess the effect of this drug on colonic epithelial apoptosis and cell proliferation in these patients.

II. Assess the effect of this drug on rectal prostaglandin levels in these patients.

III. Assess the effect of this drug on platelet cyclooxygenase activity in these patients.

IV. Correlate changes in spectral markers with UGT1A6 genotype in patients treated with this drug.

OUTLINE: This is a multicenter, randomized, double-blind, placebo-controlled study. Patients are stratified by clinical site and adenoma/carcinoma maximal size. Patients with abnormal spectral biomarkers are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral acetylsalicylic acid (aspirin) once daily.

ARM II: Patients receive oral placebo once daily.

In both arms, treatment continues for 3 months in the absence of unacceptable toxicity.

Patients undergo flexible sigmoidoscopy and biopsies as well as blood collection at baseline (during prestudy colonoscopy) and at completion of study treatment for comparison of spectral signatures with biomarkers of both aspirin activity (including plasma cyclooxygenase activity and rectal prostaglandin levels) as well as with biomarkers associated with antineoplastic alteration (including apoptosis and cell proliferation). UGT1A6 genotyping analysis is also performed.

After completion of study treatment, patients are followed at 3 months.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Colon Cancer
  • Precancerous Condition
  • Rectal Cancer
  • Drug: acetylsalicylic acid
    Given orally
    Other Names:
    • ASA
    • Ecotrin
    • Empirin
    • Extren
  • Drug: placebo
    Given orally
    Other Name: PLCB
  • Other: laboratory biomarker analysis
    Correlative study
  • Experimental: Arm I
    Patients receive oral acetylsalicylic acid (aspirin) once daily.
    Interventions:
    • Drug: acetylsalicylic acid
    • Other: laboratory biomarker analysis
  • Placebo Comparator: Arm II
    Patients receive oral placebo once daily.
    Interventions:
    • Drug: placebo
    • Other: laboratory biomarker analysis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
115
Not Provided
December 2009   (final data collection date for primary outcome measure)

Criteria:

  • No active or metastatic cancer within the past 6 months
  • Scheduled to undergo colonoscopy for colonic neoplasia surveillance
  • Hemoglobin >= 12.0 g/dL
  • Platelet count >= 120,000/mm^3
  • AST or ALT =< 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase =< 1.5 times ULN
  • Bilirubin =< 1.5 times ULN
  • BUN =< 40 mg/dL
  • Glomerular filtration rate >= 45 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No coagulopathy
  • No anemia
  • No history of peptic ulcer disease or gastrointestinal hemorrhage
  • No history of cerebrovascular accident
  • No uncontrolled hypertension
  • No history of intolerance or allergy to aspirin or to NSAIDs
  • No liver disease as manifested by signs or symptoms of cirrhosis
  • No endoscopic or radiographic evidence of portal hypertension
  • No active colitis by endoscopy
  • No history of inflammatory bowel disease
  • No requirement for aspirin as medical therapy (i.e., post-myocardial infarction or transient ischemic attack)
  • No untreated helicobacter pylori infection
  • History of significant colonic neoplasia, defined as 1 of the following:

    • Adenoma within the past 6 years
    • Colorectal cancer within the past 6 years
    • Known adenoma on present exam
    • Histologically confirmed polyps seen on imaging
  • INR =< 1.5
  • At least 6 months since prior cancer treatment
  • No other concurrent acetylsalicylic acid (aspirin)-containing products or non-steroidal anti-inflammatory drugs (NSAIDs)
  • No concurrent systemic corticosteroids
  • No other concurrent anticoagulants or antiplatelet agents
  • No concurrent investigational drugs
Both
up to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00468910
NCI-2009-00841, NCI-2009-00841, CDR0000652929, NCI 04-2-03, NWU04-2-03, N01CN35157
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Principal Investigator: Hemant Roy Northwestern University
National Cancer Institute (NCI)
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP