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

Vanderbilt University

Status and phase: Completed; Phase 1

Conditions: Gastric Cancer; Precancerous Condition

Treatments: Biological: Cetuximab

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00477880

P30CA068485 (U.S. NIH Grant/Contract)

VU-VICC-GI-0602

CDR0000546501

VU-VICC-IRB-000851

Details and patient eligibility

About

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.

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Cetuximab

Experimental group

Description:

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.

Treatment:

Biological: Cetuximab