Status:
COMPLETED
Pilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Pancreatic Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 p...
Detailed Description
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 p...
Eligibility Criteria
Inclusion
- pathologically confirmed adenocarcinoma of the pancreas
- resectable disease
- tumor \</= 6cm diameter
- ECOG performance 0-1
- Organ system fxn: granulocytes (\>/=1800/uL); plt ct \>/=100K; bili\</=2mg; liver enzymes \<2.5ULN; crt \</=1.5;
- Normal CXR
- Negative pregnancy test
Exclusion
- metastatic disease or peritoneal seeding based on cross-sectional imaging
- previous irradiation to the planned field
- prior chemotherapy or immunotherapy
- active infection
- active PUD
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00243854
Start Date
November 1 2005
End Date
October 1 2011
Last Update
March 18 2014
Active Locations (1)
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1
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202