Phase 2
Completed N=107
Acetylsalicylic Acid and Eflornithine in Treating Patients at High Risk for Colorectal Cancer
Adenomatous Polyp
Source: ClinicalTrials.gov NCT00983580 ↗
Enrolled (actual)
107
Serious AEs
1.0%
Results posted
Apr 2018
Primary outcomePrimary: Adenoma Recurrence Rate for the Treatment Arm Relative to Placebo — 0.595; 0.581 proportion of participants — p=0.448
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adenoma Recurrence Rate for the Treatment Arm Relative to Placebo |
0.595; 0.581 | 0.448 |
| SECONDARY ACF Characteristics vs Adenoma Recurrence Rate |
-20.8; -45.0 | 0.358 |
| SECONDARY Characterization of ACF |
11; 7 | — |
| SECONDARY Comparison of the Percent Change in ACF Number Across the 2 Treatment Arms |
-28.6; 10.6 | 0.513 |
| SECONDARY Safety, Tolerability, and Adverse Events of Study Treatment |
0; 3; 0; 0 | — |
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 = = 100,000/ul
- White blood cell count (WBC) >= 3,000/ul
- Alanine aminotransferase (ALT) = = 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 = = 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 weeks (Exception: low dose aspirin [81 mg] for those subjects who are chronic users of aspirin prior to the beginning of the study)
Data sourced from ClinicalTrials.gov (NCT00983580). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.