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

Gastric Cancer Clinical Trial

Official title:

Treatment of Ménétrier's Disease With EGF Receptor Blockade

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00477880
• Other study ID #: CDR0000546501
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2007
• Last updated: January 6, 2017
• Start date: April 2001
• Est. completion date: September 2010

Study information

• Verified date: January 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00268736

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastric Cancer
• Precancerous Condition
• Precancerous Conditions
• Stomach Neoplasms

Intervention

Biological:
• Cetuximab

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response		4 weeks	No