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

This study is currently recruiting participants.

Verified by National Cancer Institute (NCI), October 2008

First Received: May 23, 2007 Last Updated: August 11, 2009 History of Changes

Sponsor:	Vanderbilt-Ingram Cancer Center
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00477880

Purpose

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.

Condition	Intervention
Gastric Cancer Precancerous/Nonmalignant Condition	Biological: cetuximab

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized
Official Title:	Treatment of Ménétrier's Disease With EGF Receptor Blockade

Resource links provided by NLM:

MedlinePlus related topics: Cancer Stomach Cancer

Drug Information available for: Cetuximab

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response [ Designated as safety issue: No ]

Estimated Enrollment:	10
Study Start Date:	April 2001
Estimated Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

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

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00477880

Locations

United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Robert Coffey 615-322-4967
Vanderbilt-Ingram Cancer Center at Franklin	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Robert Coffey 615-591-9890
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Robert J. Coffey, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000546501, VU-VICC-GI-0602, VU-VICC-IRB-000851
Study First Received:	May 23, 2007
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00477880 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

gastric cancer
giant hypertrophic gastritis

Additional relevant MeSH terms:

Digestive System Neoplasms
Precancerous Conditions
Antineoplastic Agents
Gastrointestinal Diseases
Cetuximab
Pharmacologic Actions
Gastritis, Hypertrophic
Neoplasms

Digestive System Diseases
Stomach Diseases
Neoplasms by Site
Therapeutic Uses
Stomach Neoplasms
Gastrointestinal Neoplasms
Gastroenteritis
Gastritis

ClinicalTrials.gov processed this record on November 27, 2009