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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00335504 |
RATIONALE: Chemoprevention is the use of certain drugs or substances to keep cancer from forming, growing, or coming back. The use of atorvastatin, oligofructose-enriched inulin, or sulindac may stop cancer from forming in patients at increased risk of colorectal neoplasia. It is not yet known whether atorvastatin, oligofructose-enriched inulin, or sulindac are more effective than a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia.
PURPOSE: This randomized phase II trial is studying atorvastatin to see how well it works compared to oligofructose-enriched inulin, sulindac, or a placebo in preventing cancer in patients at increased risk of developing colorectal neoplasia.
Condition | Intervention | Phase |
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Colorectal Cancer Precancerous/Nonmalignant Condition |
Dietary Supplement: oligofructose-enriched inulin Drug: atorvastatin calcium Drug: sulindac Other: placebo |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | Randomized Phase II Trial of Atorvastatin, RAFTILOSE®Synergy1, and Sulindac Among Patients at Increased Risk for Sporadic Colorectal Neoplasia |
Estimated Enrollment: | 112 |
Study Start Date: | March 2006 |
Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral atorvastatin once daily.
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Drug: atorvastatin calcium
Given orally
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Arm II: Experimental
Patients receive oral sulindac twice daily.
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Drug: sulindac
Given orally
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Arm III: Experimental
Patients receive oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
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Dietary Supplement: oligofructose-enriched inulin
Given orally
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Arm IV: Placebo Comparator
Patients receive an oral placebo twice daily.
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Other: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, prospective, randomized, partially blinded, placebo-controlled study. Patients are stratified according to history of prior surgical resection of the colon (yes vs no) and number of rectal aberrant cryptic foci (ACF) (5-9 vs ≥ 10). Patients are randomized to 1 of 4 treatment arms.
Tissue samples are collected at baseline and at the completion of study treatment. Tissue is examined by immunohistochemistry for proliferation (Ki67) and apoptosis (cleaved caspase-3).
After completion of study treatment, patients are followed at approximately 30 days.
PROJECTED ACCRUAL: A total of 112 patients will be accrued for this study.
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
At increased risk for developing sporadic colorectal neoplasia, as defined by 1 of the following:
History of colon cancer (excluding stage IV or Dukes' D tumors)
History of colorectal adenomas, meeting any of the following criteria:
At least 5 rectal aberrant cryptic foci (ACF), by magnification chromoendoscopy, meeting both of the following criteria:
PATIENT CHARACTERISTICS:
No uncontrolled intercurrent illness including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
At least 6 months since prior and no concurrent regular use* of nonsteroidal anti-inflammatory drugs** (NSAIDs) or statins
No concurrent use of any of the following:
NOTE: **Patients may be eligible for study treatment after discontinuing NSAIDs for 12 weeks, at the discretion of their health care provider
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259-5499 | |
United States, California | |
Kaiser Permanente - Division of Research - Oakland | |
Oakland, California, United States, 94612 | |
United States, Connecticut | |
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center | |
Farmington, Connecticut, United States, 06360-2875 | |
United States, Illinois | |
University of Illinois Cancer Center | |
Chicago, Illinois, United States, 60612-7243 | |
Veterans Affairs Medical Center - Hines | |
Hines, Illinois, United States, 60141 | |
United States, Indiana | |
Indiana University Melvin and Bren Simon Cancer Center | |
Indianapolis, Indiana, United States, 46202-5289 | |
United States, Massachusetts | |
Dana-Farber/Brigham and Women's Cancer Center | |
Boston, Massachusetts, United States, 02115 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Pennsylvania | |
Fox Chase Cancer Center - Philadelphia | |
Philadelphia, Pennsylvania, United States, 19111-2497 | |
UPMC Cancer Center at UPMC Presbyterian | |
Pittsburgh, Pennsylvania, United States, 15213 | |
Canada, Ontario | |
University of Toronto | |
Toronto, Ontario, Canada, M5G 1X5 |
Study Chair: | Paul J. Limburg, MD, MPH | Mayo Clinic |
Responsible Party: | Mayo Clinic Cancer Center ( Paul J. Limburg ) |
Study ID Numbers: | CDR0000467755, MAYO-030103, MAYO-1395-05 |
Study First Received: | June 8, 2006 |
Last Updated: | April 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00335504 History of Changes |
Health Authority: | United States: Federal Government |
colon cancer rectal cancer precancerous/nonmalignant condition |
Antimetabolites Anti-Inflammatory Agents Precancerous Conditions Gastrointestinal Diseases Rectal Neoplasms Colonic Diseases Rectal Diseases Anti-Inflammatory Agents, Non-Steroidal Analgesics Digestive System Neoplasms Antilipemic Agents Cyclooxygenase Inhibitors Rectal Neoplasm Anticholesteremic Agents |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Intestinal Diseases Intestinal Neoplasms Calcium, Dietary Rectal Cancer Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Sulindac Peripheral Nervous System Agents Antirheumatic Agents Colorectal Neoplasms Atorvastatin |
Antimetabolites Anti-Inflammatory Agents Precancerous Conditions Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Colonic Diseases Rectal Diseases Neoplasms by Site Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Digestive System Neoplasms |
Antilipemic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Sulindac Peripheral Nervous System Agents Antirheumatic Agents |