Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer
Condition: Adenomatous Polyp
MeSH terms: Adenomatous Polyps
Intervention: Aspirin; Eflornithine; Laboratory Biomarker Analysis; Placebo; Telephone-Based Intervention
Intervention description: Given PO; Given PO; Correlative study; Given PO; Ancillary studies
Intervention MeSH terms: Aspirin; Eflornithine
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 107.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving acetylsalicylic acid together with
      eflornithine works in treating patients at high risk for colorectal cancer. Chemoprevention
      is the use of certain drugs to keep cancer from forming. The use of acetylsalicylic acid and
      eflornithine may prevent colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current or prior advanced adenomas

          -  Advanced adenomas are defined as subject with polyps >= 1 cm, tubulovillous adenomas
             (25-75 percent villous features), villous adenomas (> 75 percent villous), or
             high-grade dysplasia

          -  Prior colon cancer (>= 3 years out from invasive cancer)

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1

          -  Ability to under and the willingness to sign a written informed consent document

          -  Willingness to provide mandatory tissue for research purposes

          -  Negative pregnancy test =< 7 days prior to randomization

          -  Hemoglobin (Hgb) within normal limits for institution/lab

          -  Platelet count >= 100,000/ul

          -  White blood cell count (WBC) >= 3,000/ul

          -  Alanine aminotransferase (ALT) =< 2 x institutional upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) =< 2 x institutional ULN

          -  Total bilirubin =< 1.5 x institutional ULN

          -  Serum calcium =< institutional ULN

          -  Serum creatinine =< 1.5 x institutional ULN

          -  Colonoscopy =< 45 days prior to randomization with removal of all adenomas or polyps
             >= 2 mm in size

        Exclusion Criteria:

          -  Any history of current or prior rectal cancer

          -  Known diagnosis of colon heritable cancer syndrome (familial adenomatous polyposis
             [FAP], hereditary nonpolyposis colorectal cancer [HNPCC]) or inflammatory bowel
             disease (Crohn's disease, ulcerative colitis)

          -  Inability to swallow pills

          -  Bleeding diathesis

          -  New diagnosis of carcinoma

          -  History of hypersensitivity to COX-2 inhibitors, sulfonamides, nonsteroidal
             antiinflammatory drugs (NSAIDs), salicylates, or ursodeoxycholic acid

          -  History of gastroduodenal ulcers documented =< 1 year

          -  Known inability to participate in the scheduled follow-up tests

          -  Significant medical or psychiatric problems which would make the subject a poor
             protocol candidate, in the opinion of the treating physician

          -  Total colectomy

          -  Patients with a colostomy

          -  History of pelvic or rectal radiation therapy

          -  History of invasive carcinoma =< 5 years (except subjects with Dukes A/B1 carcinoma =<
             5 years prior to pre-registration or any stage of colon cancer if >= 3 years post
             surgical resection)

          -  Acute liver disease, unexplained transaminase elevations, or elevated serum calcium

          -  History of allergic reactions attributed to compounds of similar chemical composition
             to the study agents

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia

          -  Concomitant corticosteroids or anticoagulants needed on a regular or predictable
             intermittent basis

          -  New diagnosis of invasive carcinoma

          -  Use of non-study investigational agent(s) =< 3 months prior to randomization

          -  Chemotherapy =< 6 months prior to randomization (Note: topical chemotherapy will be
             assessed on a case-by-case basis)

          -  Pregnant women

          -  Nursing women

          -  Men or women of childbearing potential who are unwilling to employ adequate
             contraception

          -  Regular use of NSAIDs =< 6 weeks prior to randomization, defined as a frequency of 7
             consecutive days (1 week) for > 3 weeks (Exception: low dose aspirin [81 mg] for those
             subjects who are chronic users of aspirin prior to the beginning of the study)