Trial Information

A Phase II Protocol in Borderline Resectable Pancreatic Cancer Using Gemcitabine/Docetaxel Chemotherapy and An Oxaliplatin-Based Chemoradiation.

Subjects must have biopsy proven adenocarcinoma of the pancreas which is bidimensionally
measurable on CT. Cancer must be considered locally advanced (not able to be treated
surgically). Subjects must not have received prior treatment for pancreatic cancer.
Subjects must not have received prior radiation therapy to the abdomen or pelvis (for any
reason). Subjects cannot be receiving immunosuppressive therapy (e.g. prednisone,
methotrexate). Eligible subjects will receive initial chemotherapy regimen to include eight
cycles of Gemcitabine and Docetaxel. All subjects will be re-evaluated for surgery - if
tumor has shrunk enough, subject will undergo surgery, followed by additional chemotherapy
of Oxaliplatin, 5FU and Alpha-interferon and radiation therapy; once subject has recovered
from side effects of the chemo/radiation therapy, they will receive a final chemotherapy
regimen of four cycles of Gemcitabine and docetaxel. Subjects who are not surgical
candidates after eight cycles of chemotherapy will undergo an additional four cycles of
Gemcitabine and docetaxel followed by reassessment for surgery. If they are a surgical
candidate, they will undergo surgery followed by chemo/radiation therapy regimen. If they
are not a surgical candidate, they will undergo the chemo/radiation therapy regimen.

Subjects may be removed from the study treatment for the following reasons:

- The investigator feels the subject is not benefitting from treatment

- The subject chooses to discontinue for any reason

- The subject experiences side effects which are considered to be unacceptable

- The subject has an increase in the size of their tumor