Pancreatic Cancer Clinical Trials

Title: UMCC 2011.007 A Phase II Study of Neoadjuvant FOLFIRINOX and FDR-Gemcitabine with Concurrent IMRT in Patients with Borderline Resectable Pancreatic Cancer

Purpose: This research study will examine a sequence of treatments including pre-operative chemotherapy, radiation and finally surgery for borderline resectable pancreatic cancer.
Study Description: To improve the results of current standard treatments for pancreatic cancer through development of new medications. This research treatment will evaluate the combination of two chemotherapy agents, FOLFIRINOX and gemcitabine, combined with radiation therapy. FOLFIRINOX is actually a combination of four chemotherapy agents, 5-fluorouracil, leucovorin, irinotecan and oxaliplatin. The researchers have already done studies FOLFOX chemotherapy (a combination of leucovorin, 5-fluorouracil, and oxaliplatin), as well as gemcitabine and oxaliplatin combined with radiation therapy. They want to build on the information they have from this previous research. They will use this study to determine how well people do who are treated with FOLFIRINOX, gemcitabine and radiation therapy prior to having surgery for their pancreatic cancer. The researchers will also gather more information about what type of side effects occur with this treatment.

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Title: UMCC 2011-036 Phase II Trial for Advanced pancreatic and biliary cancers

Purpose: To evaluate the combination of 3 chemotherapy drugs, gemcitabine, infusional 5-fluorouracil (5FU) and cisplatin for patients with metastatic pancreatic and biliary cancers.
Study Description: Researchers will use this study to determine how well people do who are treated with gemcitabine, infusional 5-fluorouracil (5-FU) and cisplatin. The researchers will also gather more information about what type of side effects occur with this treatment. Patients who have been treated previously with a single drug of gemcitabine and /or 5FU may be eligible for this trial. Those patients who have been treated previously with cisplatin are not eligible.

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Title: Cancer Stem Cells and Inhibition of Hedgehog Pathway Signaling in Advanced Pancreas Cancer: A Pilot Study of GDC-0449 in Combination with Gemcitabine

Purpose: Evaluate the effect of inhibition of hedgehog signaling on pancreatic cancer stem for number and percentage of pancreatic cancer stem cells before and after treatment with GDC-0449.
Study Description: An investigational drug named GDC-0449 is given which is believed to target a developmental pathway which may be important in cancer cell growth and survival. There is evidence that this same pathway is active in a tumor forming population of cells called cancer stem cells. The purpose of this study is to find out the effects, good and bad, of GDC-0049 alone, then in combination with gemcitabine, a standard treatment in pancreas cancer.

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25 patients are expected to enroll in this study.