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

This study has been completed.
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00243854
First received: October 24, 2005
Last updated: March 17, 2014
Last verified: March 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00243854

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

Additional Information:
No publications provided

Responsible Party: Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier: NCT00243854     History of Changes
Obsolete Identifiers: NCT00216307
Other Study ID Numbers: 0507-08 IUCRO-0130
Study First Received: October 24, 2005
Last Updated: March 17, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Indiana University:
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

ClinicalTrials.gov processed this record on September 18, 2014