Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma
| Status: | Archived |
|---|---|
| Conditions: | Cancer, Cancer, Pancreatic Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
| Start Date: | July 2008 |
| End Date: | December 2011 |
A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma
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.
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
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