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

Indiana University8 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

TarcevaDRUG

Tarceva: 100mg/day x 2 weeks (Days 1-14) +

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Indiana University Cancer Center

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

To determine if giving chemotherapy, radiation, and Tarceva,(EGFR-tyrosine kinase inhibitor)will have side effects that will prevent surgery following this therapy

Time frame: Surgery - No later than 6 weeks from the completion of Neoadjuvant Therapy

Data from ClinicalTrials.gov

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