Ignite Creation Date:
2024-05-05 @ 10:46 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01187901
Status:
COMPLETED
Last Update Posted:
2016-06-17
First Post:
2010-08-03
Brief Title:
A Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients
Sponsor:
University of Utah
Organization:
University of Utah
Study Overview
Official Title:
Genetic Events Leading to APC-Dependent Colon Cancer in High-Risk Families a Clinical Trial of COX and EGFR Inhibition in Familial Polyposis Patients
Status:
COMPLETED
Status Verified Date:
2016-05
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:
FAPEST
Brief Summary:
The purpose of this study is to determine in a randomized placebo-controlled phase II trial if the combination of sulindac and erlotinib causes a significant regression of duodenal and colorectal adenomas in familial adenomatous polyposis FAP and attenuated FAP AFAP patients
Detailed Description:
This will be a single-center phase-II six-month-long placebo-controlled double blinded randomized trial of the epidermal growth factor receptor EGFR inhibitor erlotinib Tarceva and the cyclooxygenase COX-2 inhibitor sulindac in patients with familial adenomatous polyposis FAP or attenuated FAP FAP is an autosomal dominant inherited colon cancer predisposition with a 100 risk of colon cancer in the absence of preventive care endoscopy and surgery Efficacious chemoprevention for duodenal adenomas is an unmet clinical need in FAP patients that would reduce the morbidity from duodenectomy and risk of duodenal adenocarcinoma Currently the only Food and Drug Administration FDA-approved chemopreventive agent is celecoxib which results in a modest reduction of duodenal and colorectal polyps and is associated with cardiac toxicity at effective doses If it can be shown that combinatorial inhibition of COX-2 and EGFR activity leads to successful regression in duodenal adenomatous polyps in FAP it could be used as an effective chemopreventive regimen in FAP patients with duodenal adenomas or who have undergone surgical resection of duodenal adenomas or have many rectal adenomas FAP and AFAP patients will be screened by endoscopy for presence of 5 or more duodenal polyps then randomized to either A erlotinib at 75 mgday and sulindac at 150 mgday or B placebo for 6 months The endpoint will be endoscopy at 6 months
Primary Aim To determine if the combination of sulindac and erlotinib causes a significant regression of duodenal polyp burden at 6 mohths in FAP and attenuated FAP patients
Secondary Aim To measure if combination of sulindac and erlotinib cause a reduction in total duodenal polyp count and change in duodenal polyp burden or count stratified by genotype and initial polyp burden
Primary Aim To determine if the combination of sulindac and erlotinib causes a significant regression of duodenal polyp burden at 6 mohths in FAP and attenuated FAP patients
Secondary Aim To measure if combination of sulindac and erlotinib cause a reduction in total duodenal polyp count and change in duodenal polyp burden or count stratified by genotype and initial polyp burden
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 |
|---|---|---|---|
| P01CA073992 | NIH | None | httpsreporternihgovquickSearchP01CA073992 |