Treatment of Ménétrier's Disease With EGF Receptor Blockade
18 Years
80 Years
Both
Gastric Cancer, Precancerous Condition
Trial Information
Treatment of Ménétrier's Disease With EGF Receptor Blockade
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed Ménétrier disease
- Symptomatic disease, including gastrointestinal symptoms which interfere with
daily life
- Patient is considering surgery
- Must have failed medical therapy that was given for 6 months
- No Helicobacter pylori infection
PATIENT CHARACTERISTICS:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No NYHA class III-IV cardiovascular disease
- No clinically unstable pulmonary disease
- No chronic disease requiring ongoing therapy for stabilization, including any of the
following:
- Uncontrolled diabetes mellitus
- Malignancy
- Thyroid disease
- Hypertension
- Active infections requiring systemic antibiotics, antivirals, or antifungals
- Uncontrolled seizure disorder
- Active neurological disease
- No unstable coagulation disorders (e.g., hemorrhagic diatheses or active bleeding
disorders) that require medical management
PRIOR CONCURRENT THERAPY:
- Not specified
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Response
Safety Issue:
No
Principal Investigator
Robert J. Coffey, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Vanderbilt-Ingram Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000546501
NCT ID:
NCT00477880
Start Date:
April 2001
Completion Date:
Related Keywords:
- Gastric Cancer
- Precancerous Condition
- gastric cancer
- giant hypertrophic gastritis
- Gastritis, Hypertrophic
- Stomach Neoplasms
- Precancerous Conditions
Name | Location |
|---|---|
| Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville, Tennessee 37064 |
| Vanderbilt-Ingram Cancer Center at Franklin | Nashville, Tennessee 37064 |
