Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00062023
Status:
TERMINATED
Last Update Posted:
2012-07-30
First Post:
2003-06-05
Brief Title:
Comparison of Sulindac Aspirin and Ursodiol in Preventing Colorectal Cancer
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase II Study Of Colorectal ACF Screening Regression And Prevention In High Risk Participants
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study closed by the NCI
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
PURPOSE This randomized phase II trial is studying how well sulindac works compared to aspirin or ursodiol in preventing colorectal cancer
Detailed Description:
OBJECTIVES
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000304433 | REGISTRY | NCI PDQ | httpsreporternihgovquickSearchP30CA016672 |
| P30CA016672 | NIH | None | None |
| MDA-ID-01454 | OTHER | None | None |