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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00477880
First received: May 23, 2007
Last updated: May 14, 2010
Last verified: May 2010
  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 Condition
Biological: cetuximab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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 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
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-Ingram Cancer Center
Investigators
Study Chair: Robert J. Coffey, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00477880     History of Changes
Obsolete Identifiers: NCT00268736
Other Study ID Numbers: CDR0000546501, VU-VICC-GI-0602, VU-VICC-IRB-000851
Study First Received: May 23, 2007
Last Updated: May 14, 2010
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
gastric cancer
giant hypertrophic gastritis

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

ClinicalTrials.gov processed this record on April 23, 2014