Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00033371
Status:
COMPLETED
Last Update Posted:
2020-09-29
First Post:
2002-04-09
Brief Title:
Celecoxib With or Without Eflornithine in Preventing Colorectal Cancer in Patients With Familial Adenomatous Polyposis
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Two-Arm Phase II Chemoprevention Trial in Adenomatous Polyposis Coli Patients
Status:
COMPLETED
Status Verified Date:
2020-09
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:
This randomized phase II trial studies how well giving celecoxib with or without eflornithine works in preventing colorectal cancer in patients with familial adenomatous polyposis Chemoprevention is the use of certain drugs to keep cancer from forming The use of celecoxib and eflornithine may keep cancer from forming in patients with familial adenomatous polyposis
Detailed Description:
PRIMARY OBJECTIVES
I To determine the relative efficacy of celecoxib plus eflornithine DFMO versus celecoxib plus DFMO placebo in participants with familial adenomatous polyposis FAP as evidenced by the percent change from baseline in the number of polyps in focal areas of the colorectum in participants having 5 or more 2mm colorectal polyps with or without duodenal polyps at baseline
II To determine the relative tolerability and safety of celecoxib DFMO in FAP study participants
SECONDARY OBJECTIVES
I To determine the percent change in polyp size in focal areas of the colorectum II To determine the change in global colorectal polyp burden III To determine the percent change in the area of plaque-like duodenal polyps in participants presenting with duodenal disease at baseline
IV To analyze the effects of these agents on the following panel of mucosal biomarkers antigen identified by monoclonal antibody Ki-67 Ki-67 mitotic index number and spatial distribution of mitoses phosphorylated histone H3 cyclin-dependent kinase inhibitor 1A p21WAF1Cip1 apoptosis Terminal deoxynucleotidyl transferase dUTP nick end labeling TUNEL apoptotic index BCL2-associated X protein Bax B-cell CLLlymphoma 2 Bcl-2 and measurement of drug effects in colonic polyp and normal tissue cyclooxygenase cyclooxygenase-1 COX-1 cyclooxygenase-2 COX-2 protein levels prostaglandin E2 PGE2 ornithine decarboxylase and polyamines
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive celecoxib orally PO twice daily BID and placebo PO daily
ARM II Patients receive celecoxib PO BID and eflornithine PO daily
In both arms treatment continues for 6 months in the absence of disease progression or unacceptable toxicity
After completion of just treatment patients are followed up at 1-2 months
I To determine the relative efficacy of celecoxib plus eflornithine DFMO versus celecoxib plus DFMO placebo in participants with familial adenomatous polyposis FAP as evidenced by the percent change from baseline in the number of polyps in focal areas of the colorectum in participants having 5 or more 2mm colorectal polyps with or without duodenal polyps at baseline
II To determine the relative tolerability and safety of celecoxib DFMO in FAP study participants
SECONDARY OBJECTIVES
I To determine the percent change in polyp size in focal areas of the colorectum II To determine the change in global colorectal polyp burden III To determine the percent change in the area of plaque-like duodenal polyps in participants presenting with duodenal disease at baseline
IV To analyze the effects of these agents on the following panel of mucosal biomarkers antigen identified by monoclonal antibody Ki-67 Ki-67 mitotic index number and spatial distribution of mitoses phosphorylated histone H3 cyclin-dependent kinase inhibitor 1A p21WAF1Cip1 apoptosis Terminal deoxynucleotidyl transferase dUTP nick end labeling TUNEL apoptotic index BCL2-associated X protein Bax B-cell CLLlymphoma 2 Bcl-2 and measurement of drug effects in colonic polyp and normal tissue cyclooxygenase cyclooxygenase-1 COX-1 cyclooxygenase-2 COX-2 protein levels prostaglandin E2 PGE2 ornithine decarboxylase and polyamines
OUTLINE Patients are randomized to 1 of 2 arms
ARM I Patients receive celecoxib orally PO twice daily BID and placebo PO daily
ARM II Patients receive celecoxib PO BID and eflornithine PO daily
In both arms treatment continues for 6 months in the absence of disease progression or unacceptable toxicity
After completion of just treatment patients are followed up at 1-2 months
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 |
|---|---|---|---|
| N01CN95040 | OTHER | US NIH GrantContract Award Number | httpsreporternihgovquickSearchP30CA016672 |
| NCI-2013-00844 | REGISTRY | None | None |
| N01-CN95040 | None | None | None |
| CDR0000069278 | None | None | None |
| NCI-P02-0219 | None | None | None |
| ID00-109 | OTHER | None | None |
| P30CA016672 | NIH | None | None |
| MDA-ID-00109 | OTHER | None | None |
| N01-CN-95040 | OTHER | None | None |