Conditions: Pancreatic Cancer
Keywords: Locally advanced Unresectable
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 12
Healthy volunteers: no

Brief summary:
The primary purpose of this trial is to define the maximum tolerated and/or recommended phase II dose of the combination of Avastin and Tarceva in patients undergoing radiation therapy for carcinoma of the pancreas. An additional primary objective is to describe the frequency and nature of grade III/IV and grade I/II toxicities associated with this regimen. Secondary objectives include describing 1-year disease-free survival and overall survival rates as well as to estimate clinical and pathologic complete response rates associated with this regimen.

Detailed description:
This is a phase I/II study in which up to 18 patients will be enrolled in the phase I portion and up to an additional 26 patients in the phase II portion. Patients will be treated with Tarceva (cohort specified dose), along with fixed doses of Avastin and radiation therapy.

Avastin will be given as an IV dose on days 1, 15, and 29. Tarceva will be given as a once daily by mouth. On radiation days Tarceva will be taken immediately before or after XRT.

XRT will be given to a total dose of 50.4 Gy in 28 fractions, each fraction given once daily on Monday through Friday for 5.5 weeks

Arms:
arm 1: Avastin, Tarceva and Radiation Therapy

Interventions: intervention 1: Avastin intervention 2: Tarceva intervention 3: Radiation Therapy
Intervention descriptions: intervention 1: Avastin 10 mg/kg IV on days 1, 15 and 29 Begins the first day of radiation therapy intervention 2: Daily by mouth per assigned dose, for 5.5 weeks Begins the first day of radiation therapy intervention 3: Radiation to the pancreas Monday through Friday for 28 treatments

Protocol document: