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

Indiana University School of Medicine

Status and phase: Completed; Phase 1

Conditions: Pancreatic Cancer

Treatments: Drug: Tarceva

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00243854

0507-08 IUCRO-0130

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)