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Pilot Study Using Neoadjuvant Chemo-Radiotherapy and EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

Pilot Study Using Neoadjuvant Chemo-Radiotherapy and EGFR-tyrosine Kinase Inhibitor for Potentially Resectable Pancreatic Cancer


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.


Inclusion Criteria:



- pathologically confirmed adenocarcinoma of the pancreas

- resectable disease

- tumor
- ECOG performance 0-1

- Organ system fxn: granulocytes (>/=1800/uL); plt ct >/=100K; bili enzymes <2.5ULN; crt
- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine if giving chemotherapy, radiation, and Tarceva,(EGFR-tyrosine kinase inhibitor)will have side effects that will prevent surgery following this therapy

Outcome Time Frame:

Surgery - No later than 6 weeks from the completion of Neoadjuvant Therapy

Safety Issue:

Yes

Principal Investigator

Higinia Cardenes, M.D., PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Indiana University

Authority:

United States: Institutional Review Board

Study ID:

0507-08 IUCRO-0130

NCT ID:

NCT00243854

Start Date:

November 2005

Completion Date:

October 2011

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Cancer
  • Resectable Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • Pancreatic Neoplasms

Name

Location
Indiana University Cancer Center Indianapolis, Indiana  46202-5265