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

Pilot Study Using Neoadjuvant Chemo-Radiotherapy and EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00243854

Enrollment

Registered

2005-10-25

Start date

2005-11-30

Completion date

2011-10-31

Last updated

2014-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer, Resectable Pancreatic Cancer, adenocarcinoma of the pancreas

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

Interventions

DRUGTarceva

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026