Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery

- Cycle 1 and 2:

- Days 4, 11 and 25, 32 ....gemcitabine 750 mg/m^2 intravenous piggy back (IVPB) over
30 min

- Days 4, 11 and 25, 32 ....docetaxel 30 mg/m^2 IVPB over 1 hour

- Days 1-14 and 22-35 ....capecitabine 750 mg/m^2 oral twice daily

- Each cycle is 21 days long

- SRS: Day 43 ....25 Gy single fraction to the pancreatic tumor gross target volume

- Cycle 3 and 4:

- Days 54, 61 and 75, 82 ....gemcitabine 750 mg/m^2 IVPB over 30 min

- Days 54, 61 and 75, 82 ....docetaxel 30 mg/m^2 IVPB over 1 hour

- Days 51-64 ....capecitabine 750 mg/m^2 oral twice daily

- Each cycle is 21 days long

- Surgery: Exploratory laparotomy or laparoscopy followed by pancreaticoduodenectomy or
central pancreatectomy with or without vein resection and reconstruction as appropriate.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma
that is borderline resectable disease. Borderline resectable lesions are defined as:

- circumferential tumor abutment with the superior mesenteric vein (SMV) or portal
vein (PV) or SMV/PV confluence over < 180o.

- circumferential tumor abutment with the superior mesenteric artery (SMA) over <
180o.

- Short segment encasement (360o) of the PV or SMV that is amenable to partial vein
resection and reconstruction.

- encasement of the gastroduodenal artery up to the origin of the hepatic artery

- Patients must have measurable disease.

- No previous chemotherapy or radiation to the pancreas.

- Eastern Cooperative Oncology Group (ECOG) performance status <2 (Karnofsky >60%.

- Patients must have normal organ and marrow function as defined below:

- leukocytes >3,000/μL

- absolute neutrophil count >1,000/μL

- platelets >100,000/μL

- creatinine within normal institutional limits - OR - creatinine clearance >60
mL/min/1.73 m2 for patients with creatinine levels above institutional normal

- total bilirubin < institutional upper limit of normal (ULN). Patients may have
biliary stents or drains to lower total bilirubin to this range.

- Aspartate Aminotransferase (AST) serum glutamic oxaloacetic transaminase(SGOT) /
alanine aminotransferase (ALT) serum glutamic pyruvic transaminase(SGPT) AST and
ALT may be up to 2.5 times ULN if alkaline phosphatase < ULN; or alkaline
phosphatase may be up to 4 times ULN if AST and ALT are < ULN.

- Has a negative serum or urine pregnancy test within 7 days prior to initiation of
therapy (female patients of childbearing potential). Postmenopausal women must have
been amenorrheic for at least 12 months to be considered of non-childbearing
potential. Patients will agree to continue contraception for 30 days from the date of
the last study drug administration.

- Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

- Patients with metastatic disease are ineligible. Patients who have had prior
chemotherapy for pancreatic adenocarcinoma.

- Patients who have received prior radiation to an abdominal site are not eligible.

- Prior malignancy in the last 3 years, except basal cell carcinoma, squamous cell or
in-situ cervical cancer.

- Patients with peripheral neuropathy > grade 2.

- Patients with a history of severe hypersensitivity reaction to Taxotere (docetaxel),
other drugs formulated with polysorbate 80, gemcitabine, or capecitabine.

- Patients may not be receiving any other investigational agents.

- ECOG PS 3-4

- Pregnant women are excluded from this study because gemcitabine, capecitabine, and
docetaxel are Class D agents with the potential for teratogenic or abortifacient
effects.

- Uncontrolled intercurrent illness including, but not limited to, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric
illness/social situations that would limit compliance with study requirements

- creatinine clearance < 30 ml/min (Cockcroft-Gault method).

- Patients must not have any comorbid inflammatory conditions of the bowel such as
Crohn's Disease.