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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2011-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Tarceva

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No