GTX-RT in Borderline Resectable Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Capecitabine; Gemcitabine; Docetaxel; Stereotactic body radiation therapy (SBRT); Restaging review after radiation; Surgery; 5-Fluorouracil
Intervention description: Treatment will begin with the first round of chemotherapy. Each round of chemotherapy will take 21 days. Each round or cycle will start with participants taking capecitabine pills. Participants will take tablets of capecitabine (Xeloda®) twice per day for 14 days followed by 7 days without capecitabine.; On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. First, this will consist of placing gemcitabine (Gemzar®) in a bag of fluid and giving it by vein over 30 minutes.; On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. After the gemcitabine, participants will receive docetaxel (Taxotere®) in a bag of fluid over 1 hour.; 30/40 Gy to pancreatic tumor/area of borderline resectability; After radiation, participants will be re-evaluated for surgery. Patients who have Complete Response (CR), Partial Response (PR) or stable disease (SD) will proceed with surgical exploration and resection provided they are suitable fit for surgery in the judgment of the surgical oncologist. Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT). If no surgery: then chemotherapy. If surgery: chemotherapy will be given based on response.; Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery. After surgery, chemotherapy will be given based on response.; Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT).
Intervention MeSH terms: Gemcitabine; Capecitabine; Fluorouracil; Docetaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreas; Pancreatic; Neoplasms; Stereotactic; Radiosurgery; Borderline; Resectable; Gastrointestinal; Gemcitabine; Capecitabine; Fluorouracil; Docetaxel; SBRT; GTX Chemotherapy

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 participant's tumor followed by more chemotherapy can increase the chances that the
      participant'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 </= 180°

               -  circumferential tumor abutment with the superior mesenteric artery (SMA) over </=
                  180°

               -  Short segment encasement (360°) 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 (ULN)

               -  total bilirubin will allow for 2x the upper limit of the institution. Patients
                  may have biliary stents or drains to lower total bilirubin to this range.

          -  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.

          -  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 Performance Status 3-4

          -  Pregnant or breast-feeding 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

          -  Patients must not have any comorbid inflammatory conditions of the bowel such as
             Crohn's Disease.