Status:
COMPLETED
Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenomatous Polyp
Eligibility:
All Genders
40+ years
Phase:
PHASE2
Brief 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 dru...
Detailed Description
PRIMARY OBJECTIVES: I. The proportion of subjects with an adenoma recurrence at the 1-year follow-up colonoscopy exam. This adenoma recurrence rate for difluoromethylornithine (DFMO) (eflornithine) +...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 20 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2019
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00983580
Start Date
August 20 2009
End Date
August 13 2019
Last Update
September 4 2019
Active Locations (3)
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1
University of Illinois College of Medicine - Chicago
Chicago, Illinois, United States, 60612
2
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States, 60637
3
Mayo Clinic
Rochester, Minnesota, United States, 55905