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

Primary Purpose

Gastric Cancer, Precancerous Condition

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Cetuximab
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring gastric cancer, giant hypertrophic gastritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vanderbilt-Ingram Cancer Center - Cool Springs
  • Vanderbilt-Ingram Cancer Center at Franklin
  • Vanderbilt-Ingram Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cetuximab

Arm Description

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.

Outcomes

Primary Outcome Measures

Response

Secondary Outcome Measures

Full Information

First Posted
May 23, 2007
Last Updated
January 6, 2017
Sponsor
Vanderbilt University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00477880
Brief Title
Cetuximab in Treating Patients With Ménétrier Disease at High Risk of Developing Stomach Cancer
Official Title
Treatment of Ménétrier's Disease With EGF Receptor Blockade
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Precancerous Condition
Keywords
gastric cancer, giant hypertrophic gastritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cetuximab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Cetuximab
Other Intervention Name(s)
C225
Primary Outcome Measure Information:
Title
Response
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert J. Coffey, MD
Organizational Affiliation
Vanderbilt-Ingram Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Vanderbilt-Ingram Cancer Center - Cool Springs
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center at Franklin
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37064
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-6838
Country
United States

12. IPD Sharing Statement

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

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