Nab-paclitaxel and Gemcitabine Hydrochloride Followed by Radiation Therapy Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery
Condition: Pancreatic Adenocarcinoma; Resectable Pancreatic Carcinoma
MeSH terms: Pancreatic Neoplasms
Intervention: Fluorouracil; Gemcitabine; Image Guided Radiation Therapy; Intensity-Modulated Radiation Therapy; Laboratory Biomarker Analysis; Nab-paclitaxel; Therapeutic Conventional Surgery
Intervention description: Given IV; Given IV; Undergo IG-IMRT; Undergo IG-IMRT; Correlative studies; Given IV; Undergo surgery
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel; Gemcitabine; Fluorouracil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well nab-paclitaxel and gemcitabine hydrochloride followed by
      radiation therapy before surgery work in treating patients with pancreatic cancer that can be
      removed by surgery. Chemotherapy drugs, such as nab-paclitaxel and gemcitabine hydrochloride,
      work in different ways to stop the growth of tumor cells, either by killing the cells, by
      stopping them from dividing, or by stopping them from spreading. Radiation therapy uses
      high-energy x-rays to kill tumor cells and shrink tumors. Giving nab-paclitaxel, gemcitabine
      hydrochloride, and radiation therapy before surgery may make the tumor smaller and reduce the
      amount of normal tissue that needs to be removed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have histologically or cytologically confirmed adenocarcinoma of the
             pancreas

          -  Tumors must be localized (non-metastatic) and classified as borderline resectable
             according to Americas Hepato-Pancreato-Biliary Association (AHPBA)/Society of Surgical
             Oncology (SSO)/Society for Surgery of the Alimentary Tract (SSAT) consensus criteria
             or be clinically node-positive via computed tomography (CT) or endoscopic ultrasound

               -  AHPBA/SSO/SSAT criteria (any one of the following):

                    -  Tumor-associated deformity of the SMV (superior mesenteric vein) or PV
                       (portal vein)

                    -  Abutment of the SMV or PV >= 180 degrees

                    -  Short-segment occlusion of the SMV or PV amenable to resection and venous
                       reconstruction

                    -  Short-segment involvement of the hepatic artery or its branches amenable to
                       resection and reconstruction

                    -  Abutment of the superior mesenteric artery (SMA) < 180 degrees

          -  Subjects must have measurable disease (by RECIST 1.1), defined as at least one lesion
             that can be accurately measured in at least one dimension (longest diameter to be
             recorded for non-nodal lesions and short axis for nodal lesions) as >= 20 mm with
             conventional techniques or as >= 10 mm with spiral CT scan

          -  No prior therapy for pancreatic cancer, including chemotherapy, radiation therapy,
             definitive surgery or investigational therapy

          -  Members of all races and ethnic groups will be included

          -  Eastern Cooperative Oncology Group (ECOG) performance status =< 1

          -  Absolute neutrophil count >= 1.5 K/cu mm

          -  Platelets >= 100 K/cu mm

          -  Hemoglobin >= 9.0 g/dL

          -  Total bilirubin =< 1.25 x upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
             =< 2.5 x institutional upper limit of normal

          -  Creatinine within normal institutional limits or creatinine clearance >= 60 mL/min

          -  No active prior malignancy within 3 years of registration (with the exception of
             non-melanoma skin cancer, in-situ cancers, or Rai stage 0 chronic lymphocytic leukemia
             [CLL]); if patient is disease free from a prior malignancy between 3-5 years, special
             consideration can be requested; in these cases, if the risk of recurrence at 5 years
             is less than 20%, and in the opinion of the investigator the prior malignancy will not
             affect the patient's outcome in light of newly diagnosed pancreatic cancer, the
             patient may be eligible; this will require principle investigator (PI) review and
             approval on a case by case basis, and approval will be documented in the medical
             record; all patients who have been disease free from a prior malignancy for at least 5
             years will be eligible

          -  No baseline peripheral sensory neuropathy >= grade 2

          -  Women of child-bearing potential and men must be willing to use adequate contraception
             during the entire study and for 8 weeks following completion of all chemotherapy on
             study; this includes hormonal or barrier method, or abstinence

          -  Ability to understand and the willingness to sign a written informed consent document

        Exclusion Criteria:

          -  Subjects with locally advanced, unresectable primary tumors will not be eligible

               -  This includes any of the following:

                    -  Abutment of the SMA >= 180 degrees

                    -  Occlusion of the SMV or PV with insufficient normal vein above and below
                       with which to perform venous reconstruction

                    -  Involvement of the hepatic artery with insufficient artery proximal and
                       distal to perform reconstruction

          -  Any prior therapy (chemotherapy, radiation or surgery) for pancreatic adenocarcinoma
             other than biliary decompression

          -  Subjects who are receiving any other investigational agents

          -  Subjects with known metastases

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to ABRAXANE or other agents used in the study

          -  Active infection requiring intravenous antibiotics at the time of registration

          -  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

          -  History of interstitial lung disease, idiopathic pulmonary fibrosis, silicosis,
             sarcoidosis or connective tissue disorders (including rheumatoid arthritis and
             systemic lupus erythematosus)

          -  Pregnant or breastfeeding women are excluded from this study

          -  Subjects known to be human immunodeficiency virus (HIV)-positive, including those on
             combination antiretroviral therapy, are ineligible because of the potential for
             pharmacokinetic interactions with chemotherapy; in addition, these subjects are at
             increased risk of lethal infections when treated with marrow-suppressive therapy

          -  Subjects with plastic biliary stents will be excluded; metal biliary stents are
             allowed and will not be excluded