Cetuximab in Treating Patients With Ménétrier Disease at High Risk of Developing Stomach Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Treatment of Ménétrier's Disease With EGF Receptor Blockade

Conditions
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Gastric Cancer, Precancerous Condition

Intervention / Treatment
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* Biological: Cetuximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cetuximab<br>Cetuximab lV weekly at an initial loading dose of 400 ml/m2, followed by three weekly maintenance doses of 250 mg/m2. Four infusions of C225 will be defined as a course of therapy. | Biological: Cetuximab<br> <br> * Other names: C225;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response |  | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gastric cancer, giant hypertrophic gastritis