A Phase 1 interventional study of Cetuximab in Gastric Cancer and Precancerous Condition, sponsored by Vanderbilt University. Completed at 3 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-01-10.
Sponsored by Vanderbilt University · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
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.
2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.
This study's enrollment of 9 is below the median of 67 across 2,096 interventional studies indexed under Stomach Neoplasms.
Browse Stomach Neoplasms studies →Vanderbilt University is the lead sponsor of 508 studies on the registry; 19 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed Ménétrier disease
Symptomatic disease, including gastrointestinal symptoms which interfere with daily life
PATIENT CHARACTERISTICS:
No chronic disease requiring ongoing therapy for stabilization, including any of the following:
PRIOR CONCURRENT THERAPY:
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
Also known as: C225
Response
Time frame: 4 weeks
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Vanderbilt University