A Phase I Study of Erbitux and Gemcitabine With Radiation Therapy for Locally Advanced Pancreas Cancer
- 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
PROJECTED ACCRUAL: A total of 12-30 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose
Weekly and 4 weeks after last dose of radiation
Nipun B. Merchant
Vanderbilt-Ingram Cancer Center
United States: Food and Drug Administration
VICC GI 0466
|Vanderbilt-Ingram Cancer Center||Nashville, Tennessee 37232-6838|