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Sponsors and Collaborators: |
Chao Family Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00118365 |
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of eflornithine and sulindac may prevent colorectal cancer. It is not yet known whether eflornithine and sulindac are more effective than a placebo in preventing colorectal cancer.
PURPOSE: This randomized phase III trial is studying eflornithine and sulindac to see how well they work compared to a placebo in preventing colorectal cancer in patients with colon polyps.
Condition | Intervention | Phase |
---|---|---|
Colorectal Cancer Precancerous/Nonmalignant Condition |
Drug: eflornithine Drug: sulindac |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control |
Official Title: | A Phase III Randomized, Double-Blind, Placebo-Controlled Clinical Trial of the Combination of DFMO and Sulindac to Decrease the Rate of Recurrence of Adenomatous Polyps in the Colon |
Study Start Date: | June 2005 |
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center and aspirin use (yes vs no).
Patients receive oral double placebo once daily for 4 weeks. Patients who are more than 70% compliant by pill measurement or self reporting are randomized to 1 of 2 treatment arms.
PROJECTED ACCRUAL: A total of 150 additional patients (124 randomized) will be accrued for this study within 18 months.
Ages Eligible for Study: | 40 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Screening colonoscopy performed within the past 6 months
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Gastrointestinal
No gastric or duodenal ulcers within the past 12 months
Other
Pure tone audiometry evaluation normal
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | |
Orange, California, United States, 92868 | |
Kaiser Permanente Medical Center - Sacramento | |
Sacramento, California, United States, 95825 | |
Veterans Affairs Medical Center - Loma Linda (Pettis) | |
Loma Linda, California, United States, 92357 | |
Veterans Affairs Medical Center - Long Beach | |
Long Beach, California, United States, 90822 | |
United States, Colorado | |
Veterans Affairs Medical Center - Denver | |
Denver, Colorado, United States, 80220 | |
United States, Kansas | |
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | |
Kansas City, Kansas, United States, 66160-6616 | |
Australia, South Australia | |
Flinder Medical Centres | |
Bedford Park, South Australia, Australia, 5042 |
Principal Investigator: | Frank L. Meyskens, MD, FACP | Chao Family Comprehensive Cancer Center |
Principal Investigator: | Eugene Gerner, PhD | University of Arizona |
Study ID Numbers: | CDR0000429552, UCIRVINE-UCI-2002-2261 |
Study First Received: | July 8, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00118365 |
Health Authority: | United States: Federal Government |
colon cancer rectal cancer precancerous/nonmalignant condition |
Digestive System Neoplasms Precancerous Conditions Rectal Neoplasms Gastrointestinal Diseases Colonic Diseases Colonic Polyps Polyps Intestinal Diseases Rectal Diseases Recurrence |
Intestinal Neoplasms Rectal neoplasm Digestive System Diseases Eflornithine Gastrointestinal Neoplasms Sulindac Rectal cancer Colorectal Neoplasms Adenomatous Polyps |
Anti-Inflammatory Agents Trypanocidal Agents Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Cyclooxygenase Inhibitors Enzyme Inhibitors Pharmacologic Actions Neoplasms |
Antiparasitic Agents Neoplasms by Site Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |