Clinical trial · Interventional
Cetuximab in Treating Patients With Ménétrier Disease at High Risk of Developing Stomach Cancer
Treatment of Ménétrier's Disease With EGF Receptor Blockade
NCT00477880CI-TRIAL-00025419completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cetuximab | Biological | Cetuximab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cetuximab
- 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.
- interventionNames
- Biological: Cetuximab
Primary outcomes (1)
- measure
- Response
- timeFrame
- 4 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 specifiedReferences
Publications (0)
Data not yet available
No reference posted for this study.