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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00243854
First Posted: October 25, 2005
Last Update Posted: March 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
  Purpose
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.

Condition Intervention Phase
Pancreatic Cancer Drug: Tarceva Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Using Neoadjuvant Chemo-Radiotherapy and EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer

Resource links provided by NLM:


Further study details as provided by Indiana University ( Indiana University School of Medicine ):

Primary Outcome Measures:
  • 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 ]

Enrollment: 8
Study Start Date: November 2005
Study Completion Date: October 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Tarceva
    Tarceva: 100mg/day x 2 weeks (Days 1-14) +
Detailed 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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00243854


Locations
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Genentech, Inc.
Investigators
Principal Investigator: Higinia Cardenes, M.D., PhD Indiana University
Principal Investigator: Gabriela Chiorean, M.D. Indiana University
  More Information

Additional Information:
Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00243854     History of Changes
Obsolete Identifiers: NCT00216307
Other Study ID Numbers: 0507-08 IUCRO-0130
First Submitted: October 24, 2005
First Posted: October 25, 2005
Last Update Posted: March 18, 2014
Last Verified: March 2014

Keywords provided by Indiana University ( Indiana University School of Medicine ):
Pancreatic Cancer
Resectable Pancreatic Cancer
adenocarcinoma of the pancreas

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action