A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma
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
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tarceva Maximum Tolerated Dose in mg
Tarceva maximum tolerated dose in mg
1 yr
Yes
Brian Czito, MD
Principal Investigator
Duke University Medical Center, Dept Radiation Oncology
United States: Institutional Review Board
Pro00001597
NCT00735306
July 2008
October 2011
Name | Location |
---|---|
Duke University Medical Center | Durham, North Carolina 27710 |