Phase 2
N=87
Macrogol 3350-based Oral Osmotic Laxative in Preventing Cancer in Patients at Risk of Colorectal Cancer
Adenomatous Polyp · Colorectal Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00828984 ↗Enrolled (actual)
87
Serious AEs
3.5%
Results posted
Jan 2017
Primary outcome: Primary: Difference (After Treatment Minus Before Treatment) of EGFR Expression — 0.17; -0.40; 0.21 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- macrogol 3350-based oral osmotic laxative (Drug); Placebo (Other); Laboratory Biomarker Analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Cancer Institute (NCI)
- Primary completion
- Oct 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference (After Treatment Minus Before Treatment) of EGFR Expression |
0.17; -0.40; 0.21 | — |
| SECONDARY Change in ACF Count as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies |
2.11; 1; -0.73 | — |
| SECONDARY Change in Ki-67 (Proliferation) Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies |
2.74; -0.86; -3.58 | — |
| SECONDARY Change in Mucosal Apoptosis (Cleaved Caspase-3) as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies |
-0.27; 0.25; -0.15 | — |
| SECONDARY Change in SNAIL Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies |
0.45; 0.55; 0.08 | — |
| SECONDARY Change in E-cadherin Expression as Measured in Endoscopically Normal (Non-ACF) Mucosal Biopsies |
-0.17; 0.15; -0.18 | — |
Summary
This randomized phase II trial studies how well macrogol 3350-based oral osmotic laxative (polyethylene glycol 3350) works in preventing cancer in patients at risk of colorectal cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of macrogol 3350-based oral osmotic laxative may stop cancer from growing in patients who are at risk of colorectal cancer.
Eligibility Criteria
Inclusion Criteria
- History of any size adenoma, known adenoma on present exam, or colon cancer within the last 6 years
- Scheduled for colonoscopy
- Ability to understand and the willingness to sign a written informed consent document
- Willingness to forego PEG laxative during the study period; if the patient has been on a consistent dose of non-PEG laxative for 90 days prior to study entry, the participant may continue those laxatives; participants must agree to restrict additional laxative use to the rescue medication (bisacodyl) provided
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 (equivalent to Karnofsky >= 70%)
- Leukocytes >= 3,000/uL
- Absolute neutrophil count >= 1,500/uL
- Platelets >= 100,000/uL
- International normalized ratio (INR) = 45
- Blood urea nitrogen (BUN) 2 bowel movements per day for the 90 days preceding study entry as assessed by self-report at baseline
- Average consistency of stools described as watery or loose for the 90 days preceding study entry as assessed by self-report at baseline
- Systemic chemotherapy for any cancer within 18 months prior to enrollment or evidence of active malignant disease
- Radiation to the rectum within 24 months prior to enrollment
- Polyethylene glycol use within 3 months of enrollment (except as part of colonoscopy preparation)
- Systemic corticosteroid use
- Anticoagulant therapy
- Inflammatory bowel disease
- Removal of the rectum
- Evidence of proctitis (radiation, inflammatory bowel disease [IBD], infectious, etc.) by history or endoscopy
- Other investigational agent use within 30 days prior to enrollment
- History of adverse reactions attributed to compounds of similar chemical or biologic composition to polyethylene glycol, bisacodyl or methylene blue
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnancy
- Patient must not have used suppository medication or enemas for the three months prior to the trial or for the duration of the trial except as directed for colonoscopy or flexible sigmoidoscopy procedure bowel preparation
Data sourced from ClinicalTrials.gov (NCT00828984). 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.