Back to resultsPilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer
Primary Purpose
Pancreatic Cancer
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tarceva
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Cancer focused on measuring Pancreatic Cancer, Resectable Pancreatic Cancer, adenocarcinoma of the pancreas
Eligibility 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
Sites / Locations
- Indiana University Cancer Center
Outcomes
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
Secondary Outcome Measures
Full Information
NCT ID
NCT00243854
First Posted
October 24, 2005
Last Updated
March 17, 2014
Sponsor
Indiana University School of Medicine
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00243854
Brief Title
Pilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer
Official Title
Pilot Study Using Neoadjuvant Chemo-Radiotherapy and EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Indiana University School of Medicine
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
Pancreatic Cancer, Resectable Pancreatic Cancer, adenocarcinoma of the pancreas
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Tarceva
Intervention Description
Tarceva: 100mg/day x 2 weeks (Days 1-14) +
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Higinia Cardenes, M.D., PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gabriela Chiorean, M.D.
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
12. IPD Sharing Statement
Links:
URL
http://cancer.iu.edu
Description
Indiana University Cancer Center website
Learn more about this trial
Pilot Study Using Neoadj Chemo-Rad & EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer
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