Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00043043
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2002-08-05
Brief Title:
Celecoxib in Preventing Cancer in Patients With Rectal Polyps or Colorectal Neoplasia
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Rectal Abberant Crypt Foci And Other Intermediate Biomarkers For Sporadic Colorectal Neoplasia Cross-Sectional Prevelance And Modulation By Celecoxib
Status:
COMPLETED
Status Verified Date:
2004-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Celecoxib may be effective in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia
PURPOSE Randomized phase II trial to study the effectiveness of celecoxib in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia
PURPOSE Randomized phase II trial to study the effectiveness of celecoxib in preventing colorectal cancer in patients who have a history of rectal polyps or colorectal neoplasia
Detailed Description:
OBJECTIVES
Primary
Compare the effects of celecoxib vs placebo on the number of rectal aberrant crypt foci in patients with premalignant rectal polyps or prior sporadic colorectal neoplasia
Secondary
Compare the effects of these drugs on proliferation index apoptotic index and gene expression patterns in ascending and descending colon tissue from these patients before and after treatment
Assess gene expression patterns in normal mucosa from the ascending vs descending colon in patients referred for screening surveillance or diagnostic colonoscopy
OUTLINE This is a randomized double-blind placebo-controlled chemoprevention study Patients are stratified according to age 18 to 49 vs 50 and over and number of rectal aberrant crypt foci 5-9 vs 10 or more
All patients undergo a baseline biomarker assessment and full colonoscopy to resect all neoplasms quantitate rectal aberrant crypt foci and biopsy rectal mucosa
Depending on the results of the biomarker assessments patients are randomized to 1 of 2 treatment arms Patients with no adenomas of 5 mm or greater receive no further treatment
Arm I Patients receive oral celecoxib twice daily
Arm II Patients receive oral placebo twice daily In both arms treatment continues for 6 months in the absence of unacceptable toxicity
All patients undergo an endoscopic exam of the colorectum at completion of study
PROJECTED ACCRUAL A total of 100 patients will be accrued for the baseline biomarker assessment and a total of 40 patients 20 per arm will be accrued for the chemoprevention study within 1 year
Primary
Compare the effects of celecoxib vs placebo on the number of rectal aberrant crypt foci in patients with premalignant rectal polyps or prior sporadic colorectal neoplasia
Secondary
Compare the effects of these drugs on proliferation index apoptotic index and gene expression patterns in ascending and descending colon tissue from these patients before and after treatment
Assess gene expression patterns in normal mucosa from the ascending vs descending colon in patients referred for screening surveillance or diagnostic colonoscopy
OUTLINE This is a randomized double-blind placebo-controlled chemoprevention study Patients are stratified according to age 18 to 49 vs 50 and over and number of rectal aberrant crypt foci 5-9 vs 10 or more
All patients undergo a baseline biomarker assessment and full colonoscopy to resect all neoplasms quantitate rectal aberrant crypt foci and biopsy rectal mucosa
Depending on the results of the biomarker assessments patients are randomized to 1 of 2 treatment arms Patients with no adenomas of 5 mm or greater receive no further treatment
Arm I Patients receive oral celecoxib twice daily
Arm II Patients receive oral placebo twice daily In both arms treatment continues for 6 months in the absence of unacceptable toxicity
All patients undergo an endoscopic exam of the colorectum at completion of study
PROJECTED ACCRUAL A total of 100 patients will be accrued for the baseline biomarker assessment and a total of 40 patients 20 per arm will be accrued for the chemoprevention study within 1 year
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-02-C-0194 | None | None | None |