View Clinical Trial (Medical Research Study)
Polyethylene Glycol for ACF Reduction and Biomarker Modulation in Individuals With Colorectal Cancer Risk
| City: |
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Chicago |
| State: |
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Illinois |
| Zip Code: |
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60637 |
| Conditions: |
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Colorectal Cancer - Precancerous Condition |
| Purpose: |
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RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use
of polyethylene glycol 3350 may stop cancer from growing in patients who are at risk of
colorectal cancer. It is not yet known which treatment regimen is more effective in
preventing colorectal cancer.
PURPOSE: This randomized phase II trial is studying how well polyethylene glycol 3350 works
in preventing cancer in patients at risk of colorectal cancer.
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| Study Summary: |
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This is a multicenter study. Patients are stratified according to recruitment site and
number of aberrant crypt foci (ACF) (> 20 vs 11-20 vs 5-10). Patients are randomized to one
of three treatment arms.
- Arm I: Patients receive oral low-dose polyethylene glycol (PEG) 3350 once daily.
- Arm II: Patients receive oral high-dose PEG 3350 once daily.
- Arm III: Patients receive oral placebo (i.e., maltodextrose powder) once daily. In all
arms, treatment begins within 6-10 days after colonoscopy and continues for up to 6
months in the absence of unacceptable toxicity.
Patients undergo flexible sigmoidoscopy at baseline (during prestudy colonoscopy) and at
completion of study treatment. Patients undergo biopsies of normal mucosa (i.e., at least 1
cm from an ACF) and ACF sites (if present) to obtain tissue for evaluation of treatment
response and tissue biomarkers. Tissue samples are assessed for cleaved caspase-3, Ki-67,
and SNAIL by IHC and for EGFR and E-cadherin expression by Western blot. Samples are also
analyzed for mRNA expression of EGFR and SNAIL by RT-PCR. Blood samples are collected
periodically for RNA isolation.
After completion of study treatment, patients are followed at 30 days.
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| Criteria: |
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DISEASE CHARACTERISTICS:
- History of colonic neoplasia, defined as 1 of the following:
- Colonic adenoma of any size within the past 6 years
- Known adenoma on present exam
- Colon cancer within the past 6 years
- No evidence of active malignant disease
- Scheduled to undergo colonoscopy
- Must have at least 5 aberrant crypt foci (ACF) on baseline colonoscopy
Inclusion Criteria:
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective contraception
- Willing to forego PEG laxative during the study period
- More than 3 months since prior and no concurrent suppository medication or enema,
except as directed for colonoscopy or flexible sigmoidoscopy procedure bowel
preparation
- More than 3 months since prior polyethylene glycol (PEG), except as part of
colonoscopy preparation
- Concurrent cardioprotective aspirin dose allowed provided the patient has been on a
stable dose for the past 3 months AND agrees to remain at that dose during the study
period
- Concurrent therapeutic (e.g., pain relief) NSAIDs allowed provided their use is
limited to ≤ 30 cumulative days during the study period
- Concurrent non-PEG laxatives allowed provided the dose has been stable for the past
90 days - Must agree to restrict any additional laxative use to the rescue medication
(i.e., bisacodyl) provided
Exclusion Criteria:
- uncontrolled intercurrent illness including, but not limited to, any of the
following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- psychiatric illness or social situations that would limit compliance with study
requirements
- history of adverse reactions attributed to compounds of similar chemical or biologic
composition to PEG, bisacodyl, or methylene blue
- inflammatory bowel disease
- known or suspected bowel obstruction
- average of > 2 bowel movements per day or watery or loose stools within the past 90
days as assessed by self-report at baseline
- evidence of proctitis (e.g., due to radiation, inflammatory bowel disease, infection)
by history or endoscopy
- history of baseline diarrhea
- prior removal of the rectum
- radiation to the rectum within the past 24 months
- systemic chemotherapy for any cancer within the past 18 months
- other investigational agent within the past 30 days
- concurrent systemic corticosteroids
- concurrent anticoagulant therapy
- concurrent PEG-containing laxatives
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| NCT ID: |
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NCT00828984 |
| Primary Contact: |
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Principal Investigator
Raymond C. Bergan, MD
Robert H. Lurie Cancer Center
Raymond Bergan, MD
Phone: 312-908-5284
Email: r-bergan@northwestern.edu
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| Backup Contact: |
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Email: cancertrials@northwestern.edu
Study Coordinator
Phone: 312-695-1301
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| Location Contact: |
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Chicago, Illinois 60637
United States
There is no listed contact information for this specific location.
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 21, 2013 |
| Modifications to this listing: |
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