Pilot Study Using Neoadj Chemo-Rad & EGFR-Tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer - Full Text View

Sponsors and Collaborators:	Indiana University School of Medicine Genentech
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00243854

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 I

MedlinePlus related topics: Cancer Pancreatic Cancer Radiation Therapy

Drug Information available for: Tyrosine Erlotinib hydrochloride Erlotinib

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Study Using Neoadjuvant Chemo-Radiotherapy and EGFR-Tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer

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 ]

Estimated Enrollment:	8
Study Start Date:	November 2005
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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:

Indiana University Cancer Center website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Indiana University Cancer Center ( Higinia Cardenesm MD, PhD/ Principal Investigator )
Study ID Numbers:	0507-08 IUCRO-0130
Study First Received:	October 24, 2005
Last Updated:	July 30, 2008
ClinicalTrials.gov Identifier:	NCT00243854 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Indiana University:

Pancreatic Cancer
Resectable Pancreatic Cancer
adenocarcinoma of the pancreas

Study placed in the following topic categories:

Erlotinib
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases

Gastrointestinal Neoplasms
Endocrinopathy
Adenocarcinoma
Pancrelipase
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neoplasms
Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

Pancreatic Neoplasms
Endocrine System Diseases
Pancreatic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009