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

Treatment of Ménétrier's Disease With EGF Receptor Blockade

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00477880

Enrollment

Registered

2007-05-24

Start date

2001-04-30

Completion date

2010-09-30

Last updated

2017-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer, Precancerous Condition

Keywords

gastric cancer, giant hypertrophic gastritis

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.

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.

Interventions

BIOLOGICALCetuximab

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Response	4 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026