|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | University of California, Irvine |
|---|---|
| Collaborators: |
Chao Family Comprehensive Cancer Center National Cancer Institute (NCI) |
| Information provided by: | University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00005882 |
Purpose
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of eflornithine and sulindac may be an effective way to prevent the development of colorectal cancer in patients who have had surgery to remove benign colorectal polyps.
PURPOSE: Randomized, double-blinded, phase II trial to determine the effectiveness of eflornithine plus sulindac compared to a placebo in preventing colorectal cancer in patients who have had surgery to remove benign colorectal polyps.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: eflornithine plus sulindac |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | A Phase II Clinical Trial of a Randomized, Double-Blind, Placebo Controlled Clinical Trial of DFMO and Sulindac Against Various Endpoints of Colorectal Pathobiology in a Cohort of Individuals at Increased Risk of Colorectal Carcinoma |
| Estimated Enrollment: | 324 |
| Study Start Date: | June 2000 |
| Estimated Study Completion Date: | December 2011 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: DFMO+sulindac |
Drug: eflornithine plus sulindac
Patients will be randomized to 36 months of treatment with either DFMO+sulindac or placebo.
|
| Experimental: Placebo |
Drug: eflornithine plus sulindac
Patients will be randomized to 36 months of treatment with either DFMO+sulindac or placebo.
|
OBJECTIVES:
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to aspirin use (yes vs no) and participating center.
Patients receive oral placebo daily for the first 4 weeks. Patients who are compliant and take the placebo 5 to 7 days each week are randomized to one of two treatment arms.
PROJECTED ACCRUAL: Approximately 240 patients (120 per treatment arm) 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:
At least 1 prior resected colorectal adenoma within the past 5 years
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Gastrointestinal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Arizona | |
| Arizona Cancer Center | |
| Tucson, Arizona, United States, 85724-5024 | |
| United States, California | |
| Veterans Affairs Medical Center - Loma Linda (Pettis) | |
| Loma Linda, California, United States, 92357 | |
| Chao Family Comprehensive Cancer Center | |
| Orange, California, United States, 92868 | |
| United States, Colorado | |
| University of Colorado Cancer Center | |
| Denver, Colorado, United States, 80010 | |
| Study Chair: | Frank L. Meyskens, MD, FACP | Chao Family Comprehensive Cancer Center |
More Information
| Responsible Party: | Frank L. Meyskens, Jr, Chao Family Comprehensive Cancer Center at University of California, Irvine |
| ClinicalTrials.gov Identifier: | NCT00005882 History of Changes |
| Other Study ID Numbers: | CDR0000067922, 1997-96, NCI-P00-0150 |
| Study First Received: | June 2, 2000 |
| Last Updated: | April 18, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
colon cancer rectal cancer |
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Eflornithine Sulindac Antineoplastic Agents Therapeutic Uses |
Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Trypanocidal Agents Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Cyclooxygenase Inhibitors Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents |