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Completed

NCT Number: NCT00243854

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

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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Key information

Conditions

Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tarceva

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Genentech, Inc.

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Oct 25, 2005
Registry last updated
Mar 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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