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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00477880
First Posted: May 24, 2007
Last Update Posted: January 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Robert J. Coffey, Vanderbilt University
  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 Phase
Gastric Cancer Precancerous Condition Biological: Cetuximab Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Ménétrier's Disease With EGF Receptor Blockade

Resource links provided by NLM:


Further study details as provided by Robert J. Coffey, Vanderbilt University:

Primary Outcome Measures:
  • Response [ Time Frame: 4 weeks ]

Enrollment: 9
Study Start Date: April 2001
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cetuximab
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.
Biological: Cetuximab
Other Name: C225

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00477880


Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
Study Chair: Robert J. Coffey, MD Vanderbilt-Ingram Cancer Center
  More Information

Responsible Party: Robert J. Coffey, Asst Professor, Otolaryngology, Vanderbilt University
ClinicalTrials.gov Identifier: NCT00477880     History of Changes
Obsolete Identifiers: NCT00268736
Other Study ID Numbers: CDR0000546501
P30CA068485 ( U.S. NIH Grant/Contract )
VU-VICC-GI-0602
VU-VICC-IRB-000851
First Submitted: May 23, 2007
First Posted: May 24, 2007
Last Update Posted: January 10, 2017
Last Verified: January 2017

Keywords provided by Robert J. Coffey, Vanderbilt University:
gastric cancer
giant hypertrophic gastritis

Additional relevant MeSH terms:
Stomach Neoplasms
Precancerous Conditions
Gastritis, Hypertrophic
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Gastritis
Gastroenteritis
Cetuximab
Antineoplastic Agents