Neoadjuvant Gemcitabine, Docetaxel, and Capecitabine in Combination With Stereotactic Radiosurgery
Condition: Pancreatic Neoplasms
MeSH terms: Pancreatic Neoplasms
Intervention: GTX (gemcitabine, docetaxel and capecitabine); stereotactic body radiation therapy
Intervention description: GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14; stereotactic body radiation therapy (SBRT) 25
Intervention MeSH terms: Gemcitabine; Capecitabine; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stereotactic radiosurgery; borderline resectable pancreatic cancer; gastrointestinal; pancreas

Summary:

      The purpose of this study is to find out if a program of intensive chemotherapy with
      gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation
      aimed at the patient's tumor followed by more chemotherapy can increase the chances that the
      patient's pancreatic tumor can be removed completely.
    

Eligibility criteria:

        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.