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

NCT ID: NCT00477880

Last Updated: 2017-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-04-30
• Study Completion Date: 2010-09-30

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.

Conditions

Gastric Cancer; Precancerous Condition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cetuximab

Intervention Type: BIOLOGICAL

Interventions

Cetuximab

Intervention Type: BIOLOGICAL

Other Intervention Names

C225

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Robert J. Coffey

Asst Professor, Otolaryngology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert J. Coffey, MD

Role: STUDY_CHAIR

Vanderbilt-Ingram Cancer Center

Locations

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, United States

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

P30CA068485

Identifier Type: NIH

Identifier Source: secondary_id

View Link

VU-VICC-GI-0602

Identifier Type: -

Identifier Source: secondary_id

VU-VICC-IRB-000851

Identifier Type: -

Identifier Source: secondary_id

CDR0000546501

Identifier Type: -

Identifier Source: org_study_id

NCT00268736

Identifier Type: -

Identifier Source: nct_alias