Status:
COMPLETED
Macrogol 3350-based Oral Osmotic Laxative in Preventing Cancer in Patients at Risk of Colorectal Cancer
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Adenomatous Polyp
Colorectal Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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. Chemopreventio...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate the effect of polyethylene glycol (PEG) 3350 (administered at 8 g or 17 g/day for six months) versus placebo on epidermal growth factor receptor (EGFR) expression. ...
Eligibility Criteria
Inclusion
- 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) =\< 1.5
- Total bilirubin =\< 1.5 X institutional upper limit of normal (ULN)
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 1.5 X institutional ULN
- Estimated glomerular filtration rate (eGFR) \> 45
- Blood urea nitrogen (BUN) \< 40
- Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; restricting intercourse to a surgically sterilized partner; abstinence) for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
- If patients are on a dose of cardioprotective aspirin, they must have been on a stable dose for three months prior to colonoscopy and agree to remain at that dose for the six months duration of the study; in addition, patients must agree to limit therapeutic nonsteroidal anti-inflammatory drug (NSAID) use (e.g. pain relief) to no more than 30 cumulative days during the six month duration of the trial
Exclusion
- Average of \> 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
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
87 Patients enrolled
Trial Details
Trial ID
NCT00828984
Start Date
October 1 2009
End Date
October 1 2014
Last Update
April 18 2017
Active Locations (3)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
NorthShore University HealthSystem-Evanston Hospital
Evanston, Illinois, United States, 60201
3
Boston Medical Center
Boston, Massachusetts, United States, 02118