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Sponsors and Collaborators: |
Robert H. Lurie Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00828984 |
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.
Condition | Intervention | Phase |
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Colorectal Cancer Precancerous/Nonmalignant Condition |
Drug: polyethylene glycol Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | Polyethylene Glycol for ACF Reduction and Biomarker Modulation in Individuals With CRC Risk |
Estimated Enrollment: | 140 |
Study Start Date: | September 2008 |
Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral low-dose polyethylene glycol (PEG) 3350 once daily.
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Drug: polyethylene glycol
Given orally
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Arm II: Experimental
Patients receive oral high-dose PEG 3350 once daily.
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Drug: polyethylene glycol
Given orally
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Arm III: Placebo Comparator
Patients receive oral placebo (i.e., maltodextrose powder) once daily.
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Other: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: 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.
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
History of colonic neoplasia, defined as 1 of the following:
Scheduled to undergo colonoscopy
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
Concurrent non-PEG laxatives allowed provided the dose has been stable for the past 90 days
United States, Illinois | |
Evanston Hospital | Recruiting |
Evanston, Illinois, United States, 60201-1781 | |
Contact: Clinical Trials Office - Evanston Hospital 847-570-1381 | |
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Recruiting |
Chicago, Illinois, United States, 60611-3013 | |
Contact: Clinical Trials Office - Robert H. Lurie Comprehensive Cancer 312-695-1301 cancer@northwestern.edu | |
University of Chicago Cancer Research Center | Recruiting |
Chicago, Illinois, United States, 60637-1470 | |
Contact: Clinical Trials Office - University of Chicago Cancer Research 773-834-7424 |
Principal Investigator: | Raymond C. Bergan, MD | Robert H. Lurie Cancer Center |
Responsible Party: | Robert H. Lurie Comprehensive Cancer Center at Northwestern University ( Raymond C. Bergan ) |
Study ID Numbers: | CDR0000632553, NU-NWU06-8-01, NCI-06-8-01 |
Study First Received: | January 23, 2009 |
Last Updated: | July 7, 2009 |
ClinicalTrials.gov Identifier: | NCT00828984 History of Changes |
Health Authority: | Unspecified |
colon cancer rectal cancer adenomatous polyp precancerous/nonmalignant condition |
Digestive System Neoplasms Precancerous Conditions Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Rectal Neoplasm Polyps Intestinal Diseases |
Rectal Diseases Intestinal Neoplasms Rectal Cancer Digestive System Diseases Gastrointestinal Neoplasms Colorectal Neoplasms Adenomatous Polyps |
Neoplasms Digestive System Diseases Neoplasms by Site Digestive System Neoplasms Precancerous Conditions Gastrointestinal Diseases |
Colonic Diseases Gastrointestinal Neoplasms Intestinal Diseases Rectal Diseases Intestinal Neoplasms Colorectal Neoplasms |