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| Sponsor: | Chao Family Comprehensive Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00118365 |
Purpose
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.
Eligibility| 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
Contacts and Locations| 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 |
More Information
| Study ID Numbers: | CDR0000429552, UCIRVINE-UCI-2002-2261 |
| Study First Received: | July 8, 2005 |
| Last Updated: | May 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00118365 History of Changes |
| Health Authority: | United States: Federal Government |
|
colon cancer rectal cancer precancerous/nonmalignant condition |
|
Anti-Inflammatory Agents Trypanocidal Agents Anti-Infective Agents Antiprotozoal Agents Precancerous Conditions Molecular Mechanisms of Pharmacological Action Gastrointestinal Diseases Antineoplastic Agents Physiological Effects of Drugs Colonic Diseases Rectal Diseases Antiparasitic Agents Neoplasms by Site Sensory System Agents Eflornithine |
Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Digestive System Neoplasms Cyclooxygenase Inhibitors Enzyme Inhibitors Intestinal Diseases Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Analgesics, Non-Narcotic Gastrointestinal Neoplasms Peripheral Nervous System Agents Sulindac |