Overview

This trial has been completed.

Conditions gastric cancer, precancerous condition
Treatment cetuximab
Phase phase 1
Target EGFR
Sponsor Vanderbilt University
Collaborator National Cancer Institute (NCI)
Start date April 2001
End date September 2010
Trial size 9 participants
Trial identifier NCT00477880, CDR0000546501, NCT00268736, P30CA068485, VU-VICC-GI-0602, VU-VICC-IRB-000851

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.
cetuximab C225

Primary Outcomes

Measure
Response
time frame: 4 weeks

Eligibility Criteria

Male or female participants from 18 years up to 80 years old.

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

Additional Information

Official title Treatment of Ménétrier's Disease With EGF Receptor Blockade
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.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Vanderbilt University Medical Center.