Overview

Pilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer

Status:
Completed
Trial end date:
2011-10-01
Target enrollment:
0
Participant gender:
All
Summary
To determine the feasibility and toxicity of neoadjuvant hypofractioned radiotherapy concurrently with weekly gemcitabine and an EGFR tyrosine-kinase inhibitor (OSI-774, Tarceva) in the treatment of patients with resectable pancreatic cancer.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Indiana University School of Medicine
Collaborator:
Genentech, Inc.
Treatments:
Erlotinib Hydrochloride
Criteria
Inclusion Criteria:

- pathologically confirmed adenocarcinoma of the pancreas

- resectable disease

- tumor
- ECOG performance 0-1

- Organ system fxn: granulocytes (>/=1800/uL); plt ct >/=100K; bili <2.5ULN; crt
- Normal CXR

- Negative pregnancy test

Exclusion Criteria:

- metastatic disease or peritoneal seeding based on cross-sectional imaging

- previous irradiation to the planned field

- prior chemotherapy or immunotherapy

- active infection

- active PUD