Finding studies
Finding studies
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Lead
Vanderbilt-Ingram Cancer Center
With
OBJECTIVES: * Determine the maximum tolerated dose of gemcitabine hydrochloride when administered with cetuximab and radiotherapy in patients with unresectable locally advanced pancreatic or periampullary region cancer. * Determine the toxicity of this regimen in these patients. OUTLINE: This is a dose-escalation study of gemcitabine hydrochloride. Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-7 and gemcitabine hydrochloride IV over 15-40 minutes once weekly in weeks 2-7. Patients also undergo radiotherapy 5 days a week in weeks 2-7. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed for 30 days and then every 3 months thereafter. PROJECTED ACCRUAL: A total of 12-30 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
