Overview

The objective of this research is to find out what effects (good and bad), the combination of gemcitabine and nab-paclitaxel therapy (GEM-ABR for the rest of the document), standard chemotherapy for pancreatic cancer, and the TheraBionic device has on participants' condition.

Eligibility

Inclusion Criteria:

• Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinoma of the pancreas. If a patient had a biopsy of the pancreatic mass and the clinical picture is consistent with metastatic pancreatic cancer, another biopsy of a metastatic site is not required for this trial. Pancreatic tumors with mixed histology that has predominant adenocarcinoma can be enrolled.
• One or more measurable metastatic tumors per Response Evaluation Criteria in Solid Tumors (RECIST v1.1) on imaging studies (CT or MRI) of chest, abdomen and pelvis.
• Females of childbearing potential and males with female partners of childbearing potential, if sexually active, must agree to use two forms of contraception during the period of administration of study drug and up to 6 months after the end of treatment. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
• Age 18 years old or greater.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Patients must have organ and marrow function as defined below:

        Organ and Marrow Function Absolute neutrophil count (ANC) ≥ 1,500/mcL Platelets ≥
        100,000/mcL Hemoglobin ≥ 7 g/dL *It is acceptable to transfuse packed red blood cells
        (PRBC) and platelets at the time of enrollment to meet the eligibility criteria.
        Total bilirubin ≤ 1.5 X institutional upper limit of normal AST(SGOT)/ALT(SGPT) ≤ 2.5 X
        institutional upper limit of normal (≤ 5 x ULN, if liver metastasis) Creatinine ≤ 1.5 X
        institutional upper limit of normal Or CrCL > 50
        - Ability to understand and the willingness to sign an IRB-approved informed consent
        document (either directly or via a legally authorized representative).
        Exclusion Criteria:
          -  Patients treated with any chemotherapy in metastatic setting and/or who had
             chemotherapy with gemcitabine and/or nab-paclitaxel within six months prior to
             entering the study in the adjuvant or neo-adjuvant setting are excluded. Patients who
             have had chemotherapy with FOLFIRINOX prior to entering the study in the adjuvant or
             neo-adjuvant setting can be enrolled into the study.
          -  Patients with known brain metastases are excluded from this clinical trial because of
             their poor prognosis and because they often develop progressive neurologic dysfunction
             that would confound the evaluation of neurologic and other adverse events.
          -  History of hypersensitivity or allergic reactions attributed to compounds of similar
             chemical or biologic composition to gemcitabine and nab-paclitaxel.
          -  History of malignancy in last 3 years except cervical cancer in situ, adequately
             treated basal cell or squamous cell carcinoma of skin or treated low risk prostate
             cancer, who are considered to be eligible.
          -  Patients receiving calcium channel blockers and any agent blocking L-type of T type
             Voltage Gated Calcium Channels such as amlodipine, nifedipine, ethosuximide are not
             allowed in the study unless their medical treatment is modified to exclude calcium
             channel blockers prior to enrollment.
          -  Patients with active and uncontrolled bacterial, viral or fungal infection requiring
             systemic therapy. Patients can be reevaluated for the study if the infection is deemed
             to be under control and the systemic therapy is completed.
          -  Uncontrolled intercurrent illness including symptomatic congestive heart failure,
             unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
             that would limit compliance with study requirements or could compromise patient
             safety.
          -  Known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis or
             pneumonitis.
          -  Pregnant women are excluded from this study because of potential risk for teratogenic
             or abortifacient effects. Because there is an unknown but potential risk for adverse
             events in nursing infants secondary to treatment of the mother with chemotherapy and
             amplitude-modulated radiofrequency electromagnetic fields, patients who are
             breastfeeding will be excluded to participate in this study.
          -  Localized resectable or locally advanced tumor.
          -  Undergone surgery, other than diagnostic surgery or minor procedures, within 4 weeks
             prior to the treatment day.
          -  Unable to comply with study procedures or anticipating a situation that would result
             in a treatment break for 14 or more consecutive days after the start of the study.
          -  Actively enrolled in any other clinical interventional trial or receiving any other
             investigational agents.