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

NCT00477880 | Completed Phase 1 DMC

• 4 other identifiers: CDR0000546501P30CA068485VU-VICC-GI-0602VU-VICC-IRB-000851
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 3

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.

Conditions

Gastric Cancer; Precancerous Condition

Keywords

gastric cancer; giant hypertrophic gastritis

Outcome Measures

Primary Outcomes (1)

• Response

  4 weeks

Study Arms (1)

Cetuximab

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.

Biological: Cetuximab

Interventions

Cetuximab BIOLOGICAL

Also known as: C225

Cetuximab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms; Precancerous Conditions; Gastritis, Hypertrophic

Interventions

Cetuximab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastritis; Gastroenteritis

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Robert J. Coffey, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Professor, Otolaryngology

Study Record Dates

• First Submitted: May 23, 2007
• First Posted: May 24, 2007
• Study Start: April 1, 2001
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: January 10, 2017

Record last verified: 2017-01

Locations

US (3)