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Clinical Trial: Pilot Study Using Neoadj Chemo-Rad & EGFR-Tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer
This study is not yet open for patient recruitment.
Verified by Indiana University School of Medicine October 2005
|
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: Pancreatic Cancer
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 School of Medicine:
Primary Outcomes: To determine if giving chemotherapy, radiation, and Tarceva,(EGFR-tyrosine kinase inhibitor)will have side effects that will prevent surgery following this therapy
Expected Total Enrollment: 8
Expected Total Enrollment: 8
Study start: November 2005
Last follow-up: November 2005
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 above, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00243854
Higinia Cardenes, M.D., PhD 317-274-2524 hcardene@iupui.edu
Gabriela Chiorean, M.D. 317-278-0080 gchiorea@iupui.edu
Gabriela Chiorean, M.D. 317-278-0080 gchiorea@iupui.edu
Indiana
Indiana University Cancer Center, Indianapolis, Indiana, 46202, United States
Gabriela Chiorean, M.D. 317-278-0080 gchiorea@iupui.edu
Higinia Cardenes, M.D., PhD 317-274-2524 hcardene@iupui.edu
Gabriela Chiorean, M.D., Principal Investigator
Higinia Cardenes, M.D., PhD, Principal Investigator
Higinia Cardenes, M.D., PhD 317-274-2524 hcardene@iupui.edu
Gabriela Chiorean, M.D., Principal Investigator
Higinia Cardenes, M.D., PhD, Principal Investigator
Study chairs or principal investigators
Higinia Cardenes, M.D., PhD, Principal Investigator, Indiana University School of Medicine
Gabriela Chiorean, M.D., Principal Investigator, Indiana University School of Medicine
More Information
Study ID Numbers: IUCRO-0130
Last Updated: December 8, 2005
Record first received: October 24, 2005
ClinicalTrials.gov Identifier: NCT00243854
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10
Last Updated: December 8, 2005
Record first received: October 24, 2005
ClinicalTrials.gov Identifier: NCT00243854
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2006-01-10
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