Perioperative Therapy for Resectable Pancreatic Cancer
Condition: Adenocarcinoma of the Pancreas; Stage IA Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer
MeSH terms: Adenocarcinoma; Pancreatic Neoplasms
Intervention: gemcitabine hydrochloride; docetaxel; capecitabine; intensity-modulated radiation therapy; oxaliplatin; pancreatic surgical procedure; therapeutic conventional surgery; laboratory biomarker analysis
Intervention description: Given IV; Given IV; Given PO; Undergo IMRT; Given IV; Undergo pancreaticoduodenectomy; Undergo therapeutic conventional surgery; Correlative studies
Intervention MeSH terms: Gemcitabine; Capecitabine; Docetaxel; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well giving combination chemotherapy together with
      intensity-modulated radiation therapy (IMRT) and surgery works in treating patients with
      localized pancreatic cancer that can be removed by surgery. Drugs used in chemotherapy, such
      as gemcitabine hydrochloride, docetaxel, capecitabine, and oxaliplatin, work in different
      ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
      dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized
      radiation therapy, such as IMRT, that delivers a high dose of radiation directly to the tumor
      may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug
      (combination chemotherapy) together with intensity-modulated radiation therapy before surgery
      may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
      Giving chemotherapy after surgery may kill any tumor cells that remain after surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed diagnosis of localized,
             resectable or borderline resectable, pancreatic adenocarcinoma T1-T3, N0-N1, M0; stage
             is determined by helical multi-phase computed tomography (CT) and/or endoscopic
             ultrasound according to published guidelines; resectability is determined by the
             treating surgeon and published guidelines (National Comprehensive Cancer Network)

          -  Resectable Disease- Head/Body/Tail of pancreas:

               -  No distant metastases

               -  Clear fat plane around celiac and superior mesenteric arteries (SMA)

               -  Patent superior mesenteric vein (SMV) and portal vein (PV)

          -  Borderline Resectable Disease -Head/Body of pancreas:

               -  Tumor abutment on SMA

               -  SMV/portal vein impingement or occlusion if involving only a short segment, with
                  open vein both proximally and distally (if proximal vein is occluded up to the
                  portal vein branches then disease is unresectable)

               -  Colon or mesocolon invasion

               -  Gastroduodenal artery (GDA) encasement up to origin at hepatic artery

          -  Tail of pancreas:

               -  Adrenal, colon or mesocolon, or kidney invasion

               -  Preoperative evidence of biopsy-positive peripancreatic lymph node

          -  No prior therapy for pancreatic cancer

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

          -  Leucocytes >= 3,000/uL

          -  Absolute Neutrophil Count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Total Bilirubin:

               -  If within normal limits (WNL) to =< 2.0, the subject is eligible

               -  If > 2.0 - < 6.0, subject is eligible IF they have a biliary stent and total
                  bilirubin is decreasing

               -  If >= 6.0, subject is not eligible

          -  Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvic transaminase [SGPT]) =<
             2.5 X institutional upper limit of normal or =< 1.5 X upper limit of normal (ULN) if
             alkaline phosphatase (Alk Phos) > 2.5 X ULN or if the subject has a biliary stent and
             the liver function tests (LFTs) are decreasing the subject is eligible

          -  Creatinine clearance >= 30%

          -  Negative pregnancy test for women of childbearing potential; women of childbearing
             potential and men must agree to use adequate contraception (hormonal or barrier method
             of birth control; abstinence) prior to study entry and for the duration of study
             participation; should a woman become pregnant or suspect she is pregnant while
             participating in this study, she should inform her treating physician immediately

          -  Ability to swallow and retain oral medication

          -  Ability to understand and willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Patients may not be receiving any other investigational agents

          -  Histology other than adenocarcinoma

          -  Patients with permanently unresectable pancreatic adenocarcinoma as determined by the
             treating physician and published guidelines (National Comprehensive Cancer Network)

          -  Unresectable disease

          -  Head of pancreas:

               -  Distant metastases (includes celiac and/or para-aortic)

               -  SMA, celiac encasement

               -  SMV/portal occlusion

               -  Aortic, inferior vena cava (IVC) invasion or encasement

               -  Invasion of SMV below transverse mesocolon

          -  Body of pancreas:

               -  Distant metastases (includes celiac and/or para-aortic); at the discretion of the
                  treating surgeon, body and tail lesions that have positive celiac and/or
                  para-aortic nodes in close vicinity to the primary may be borderline rather than
                  unresectable

               -  SMA, celiac, hepatic encasement

               -  SMV/portal extended occlusion

               -  Aortic invasion

          -  Tail of pancreas:

               -  Distant metastases (includes celiac and/or para-aortic)

               -  SMA, celiac encasement

               -  Rib, vertebral invasion

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to gemcitabine, docetaxel, capecitabine, oxaliplatin or other agents used
             in the study

          -  Patients who have received prior chemotherapy or radiotherapy for the diagnosis of
             pancreatic cancer

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Inability to comply with study and/or follow-up procedures

          -  Pregnancy or lactation

          -  Human immunodeficiency virus (HIV)-positive patients receiving combination
             anti-retroviral therapy