Cetuximab in Treating Patients With Ménétrier Disease at High Risk of Developing Stomach Cancer
- Conditions
- Precancerous ConditionGastric Cancer
- Interventions
- Biological: Cetuximab
- Registration Number
- NCT00477880
- Lead Sponsor
- Vanderbilt University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 9
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cetuximab 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.
- Primary Outcome Measures
Name Time Method Response 4 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (3)
Vanderbilt-Ingram Cancer Center at Franklin
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center - Cool Springs
🇺🇸Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
🇺🇸Nashville, Tennessee, United States