NCT00477880

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

Treatment of Ménétrier's Disease With EGF Receptor Blockade

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastric Cancer
• Precancerous Condition

Interventions

Type	Name	Description
BIOLOGICAL	Cetuximab

Timeline

• Start date: 2001-04-01
• Primary completion: 2010-09-01
• Completion: 2010-09-01
• First posted: 2007-05-24
• Last updated: 2017-01-10

Locations

3 sites across 1 country: United States