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

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.