Pilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer
Phase 1
Completed
- Conditions
- Pancreatic Cancer
- Registration Number
- NCT00243854
- Lead Sponsor
- Indiana University School of Medicine
- 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 patients with resectable pancreatic cancer.
- 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 patients with resectable pancreatic cancer.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
Inclusion Criteria
- 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 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method To determine if giving chemotherapy, radiation, and Tarceva,(EGFR-tyrosine kinase inhibitor)will have side effects that will prevent surgery following this therapy Surgery - No later than 6 weeks from the completion of Neoadjuvant Therapy
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Indiana University Cancer Center
🇺🇸Indianapolis, Indiana, United States