Comparison of Sulindac, Aspirin, and Ursodiol in Preventing Colorectal Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00062023|
Recruitment Status : Terminated (Study closed by the NCI.)
First Posted : June 6, 2003
Last Update Posted : July 30, 2012
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 or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: Acetylsalicylic acid (Aspirin) Drug: Sulindac Drug: Ursodiol Other: Sulindac Placebo||Phase 2|
- Determine the percentage change in colorectal aberrant crypt foci (ACF) in patients with a history of colorectal cancer or at high risk for colorectal cancer when treated with sulindac vs aspirin vs ursodiol.
- Determine the safety and efficacy of these drugs, in terms of ability to cause regression of existing colorectal ACF and prevent new ACF development, in these patients.
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.
- Arm I: Patients receive oral sulindac twice daily.
- Arm II: Patients receive oral aspirin once daily.
- Arm III: Patients receive oral ursodiol three times daily.
- Arm IV: Patients receive oral sulindac placebo twice daily. In all arms, treatment continues for 12 months in the absence of disease progression or unacceptable toxicity.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Phase II Study Of Colorectal ACF Screening, Regression And Prevention In High Risk Participants|
|Study Start Date :||June 2003|
|Primary Completion Date :||April 2005|
|Study Completion Date :||May 2006|
Active Comparator: Arm I Sulindac
Oral sulindac twice daily.
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.
Active Comparator: Arm III Ursodiol
Oral ursodiol three times daily.
Patients receive oral ursodiol three times daily for 12 months.
Placebo Comparator: Arm IV: Sulindac Placebo
Oral sulindac placebo twice daily.
Other: Sulindac Placebo
Oral sulindac placebo twice daily.
- Percentage Change in Colorectal ACF Patients Treated with Sulindac, Aspirin or Ursodiol [ Time Frame: 12 Months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00062023
|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|