Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00477880
Status:
COMPLETED
Last Update Posted:
2017-01-10
First Post:
2007-05-23
Brief Title:
Cetuximab in Treating Patients With Ménétrier Disease at High Risk of Developing Stomach Cancer
Sponsor:
Vanderbilt University
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Treatment of Ménétriers Disease With EGF Receptor Blockade
Status:
COMPLETED
Status Verified Date:
2017-01
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 Monoclonal antibodies such as cetuximab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them
PURPOSE This clinical trial is studying how well cetuximab works in treating patients with Ménétrier disease at high risk of developing stomach cancer
PURPOSE This clinical trial is studying how well cetuximab works in treating patients with Ménétrier disease at high risk of developing stomach cancer
Detailed Description:
OBJECTIVES
Evaluate clinical and biochemical parameter response in patients with Ménétrier disease at high risk of developing gastric cancer treated with cetuximab
OUTLINE This is a non-randomized study
Patients receive cetuximab IV on days 1 8 15 and 22 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients complete a quality of life questionnaire at baseline and during week 4
PROJECTED ACCRUAL A total of 10 patients will be accrued for this study
Evaluate clinical and biochemical parameter response in patients with Ménétrier disease at high risk of developing gastric cancer treated with cetuximab
OUTLINE This is a non-randomized study
Patients receive cetuximab IV on days 1 8 15 and 22 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients complete a quality of life questionnaire at baseline and during week 4
PROJECTED ACCRUAL A total of 10 patients will be accrued 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 |
|---|---|---|---|
| VU-VICC-IRB-000851 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA068485 |
| P30CA068485 | NIH | None | None |
| VU-VICC-GI-0602 | None | None | None |