• Response [ Designated as safety issue: No ]
  

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.

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