|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Sponsor: | M.D. Anderson Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00062023 |
Purpose
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. It is not yet known whether sulindac, aspirin, or ursodiol is more effective in preventing colorectal cancer.
PURPOSE: This randomized phase II trial is studying how well sulindac works compared to aspirin or ursodiol in preventing colorectal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Drug: Acetylsalicylic acid (Aspirin) Drug: Sulindac Drug: Ursodiol Other: Sulindac Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Subject) Primary Purpose: Prevention |
| Official Title: | Phase II Study Of Colorectal ACF Screening, Regression And Prevention In High Risk Participants |
| Enrollment: | 12 |
| Study Start Date: | June 2003 |
| Study Completion Date: | May 2006 |
| Primary Completion Date: | April 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Arm I Sulindac
Oral sulindac twice daily.
|
Drug: Sulindac
Patients receive oral sulindac twice daily for 12 months.
Other Name: Clinoril
|
|
Active Comparator: Arm II Aspirin
Oral aspirin once daily.
|
Drug: Acetylsalicylic acid (Aspirin)
Patients receive oral aspirin once daily for 12 months.
Other Names:
|
|
Active Comparator: Arm III Ursodiol
Oral ursodiol three times daily.
|
Drug: Ursodiol
Patients receive oral ursodiol three times daily for 12 months.
Other Names:
|
|
Placebo Comparator: Arm IV: Sulindac Placebo
Oral sulindac placebo twice daily.
|
Other: Sulindac Placebo
Oral sulindac placebo twice daily.
|
OBJECTIVES:
OUTLINE: This is a partially blinded, randomized, placebo-controlled study. Patients are stratified according to colorectal neoplasia (adenoma vs carcinoma). Patients are randomized to 1 of 4 treatment arms.
Patients undergo a colonoscopy at baseline and at the end of treatment.
Patients are followed at 2 months after the end of treatment.
PROJECTED ACCRUAL: A total of 172 patients (43 per treatment arm) with a history of colorectal cancer or adenomas will be accrued for this study. A total of 20 additional patients with no elevated risk of colorectal neoplasia will be accrued, but not randomized, for this study.
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Texas | |
| M.D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| Study Chair: | Robert S. Bresalier, MD | M.D. Anderson Cancer Center |
More Information
| Responsible Party: | Robert S. Bresalier, M.D., UT MD Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00062023 History of Changes |
| Other Study ID Numbers: | ID01-454, P30CA016672, MDA-ID-01454, CDR0000304433 |
| Study First Received: | June 5, 2003 |
| Last Updated: | August 17, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
colorectal cancer stage I colon cancer stage II colon cancer stage III colon cancer stage IV colon 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 Aspirin Sulindac Ursodeoxycholic Acid Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors |