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Pancreatic Cancer: N064A

Principal Investigator(s):Preston Steen M.D.
Sub Investigator(s):Amit Panwalkar M.D.; Anu Gaba M.D.; Denise Snow M.D.; Dennis Bier M.D.; Gerald Gross M.D.; Homayoon Shahidi M.D.; John Bollinger M.D.; John Leitch M.D.; Louis Geeraerts M.D.; Nathan Kobrinsky M.D.; Ralph Levitt M.D.; Robert Arusell M.D.; Shelby Terstriep M.D.
Condition:Cancer - GI, Pancreatic
Specialty:Oncology–Radiation
Short Title:Pancreatic Cancer: N064A
Sponsor:North Central Cancer Treatment Group
National Study ID:NCCTG N064A
Status:Open to Accrual
Description:The purpose of this research study is to find out what the effects are of adding the investigational drug panitumumab to the standard treatment for pancreatic cancer, which is 5-fluorouracil (5FU) with radiation treatment. In some cases, your doctor may decide to use a drug called capecitabine instead of 5FU. After the panitumumab and 5FU (or capecitabine) combination therapy is done, the research study will include 12 additional weeks of treatment with a combination of panitumumab and gemcitabine followed by 6 months of panitumumab alone to see if the treatment will keep your tumor from growing.
Phase:II
Key Inclusion Criteria:
* Histologically or cytology confirmed unresectable adenocarcinoma of the pancreas.
* Adequate oral nutrition.
* 18 years of age and older.
Key Exclusion Criteria:
* Evidence of metastatic disease outside of the planned radiation therapy field.
* Distant metastases.
* Chronic use of immunosuppresive agents.
* Uncontrolled intercurrent illness.
* History of interstitial lung disease.
* History or known presence of central nervous system metastases.
* Clinically significant cardiovascular disease.
* Known positive tests for human immunodeficiency virus infection, hepatitis C virus, acute or chronic active hepatitis B infection.
Contact:Sherrie Skuza
Education & Research Manager
701-234-5301
sherrie.skuza@meritcare.com
Last updated:Tuesday, October 20, 2009

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