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Phase I/II Trial of Radiation, Avastin and Tarceva for Pancreatic Adenocarcinoma — TART  

Pancreatic Cancer Clinical Trial

Official title:
A Phase I/II Trial of Radiation, Avastin and Tarceva for Resectable or Locally Advanced Pancreatic Adenocarcinoma

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00735306
Study type Interventional
Source Duke University
Contact
Status Completed
Phase Phase 1
Start date July 2008
Completion date October 2011
View Details
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