Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer
Study type: Interventional What is this?
Describes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study phase: II What is this?
During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.
- Rochester, Minnesota: 09-001758
NCT ID: NCT00983580
Sponsor Protocol Number: MC054A
About this study
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.
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.
See eligibility 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
- 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)
Participating Mayo Clinic locations
Study statuses change often. Please contact us for help.
|Mayo Clinic Location
Mayo Clinic principal investigator
Frank Sinicrope, M.D.
Open for enrollment
Cancer Center Clinical Trials Referral Office