Clinical trial NCT00477880: Cetuximab in Treating Patients With Ménétrier Disease at High Risk of Developing Stomach Cancer
Official title: Treatment of Ménétrier's Disease With EGF Receptor Blockade
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastric Cancer
Precancerous Condition
Keywords: gastric cancer
giant hypertrophic gastritis
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-05-24
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Response
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Robert J. Coffey, MD
role: STUDY_CHAIR
References: