Study of Amplitude-Modulated Radiofrequency Electromagnetic Fields in Metastatic Pancreatic Cancer

Inclusion Criteria:

• Patient must have newly diagnosed untreated biopsy proven metastatic adenocarcinomaof the pancreas. If a patient had a biopsy of the pancreatic mass and the clinicalpicture is consistent with metastatic pancreatic cancer, another biopsy of ametastatic site is not required for this trial. Pancreatic tumors with mixedhistology that has predominant adenocarcinoma can be enrolled.

• One or more measurable metastatic tumors per Response Evaluation Criteria in SolidTumors (RECIST v1.1) on imaging studies (CT or MRI) of chest, abdomen and pelvis.

• Females of childbearing potential and males with female partners of childbearingpotential, if sexually active, must agree to use two forms of contraception duringthe period of administration of study drug and up to 6 months after the end oftreatment. Should a woman become pregnant or suspect she is pregnant whileparticipating 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 consentdocument (either directly or via a legally authorized representative).

Exclusion Criteria:

• Patients treated with any chemotherapy in metastatic setting and/or who hadchemotherapy with gemcitabine and/or nab-paclitaxel within six months prior toentering the study in the adjuvant or neo-adjuvant setting are excluded. Patientswho have had chemotherapy with FOLFIRINOX prior to entering the study in theadjuvant or neo-adjuvant setting can be enrolled into the study.

• Patients with known brain metastases are excluded from this clinical trial becauseof their poor prognosis and because they often develop progressive neurologicdysfunction that would confound the evaluation of neurologic and other adverseevents.

• History of hypersensitivity or allergic reactions attributed to compounds of similarchemical or biologic composition to gemcitabine and nab-paclitaxel.

• History of malignancy in last 3 years except cervical cancer in situ, adequatelytreated basal cell or squamous cell carcinoma of skin or treated low risk prostatecancer, who are considered to be eligible.

• Patients receiving calcium channel blockers and any agent blocking L-type of T typeVoltage Gated Calcium Channels such as amlodipine, nifedipine, ethosuximide are notallowed in the study unless their medical treatment is modified to exclude calciumchannel blockers prior to enrollment.

• Patients with active and uncontrolled bacterial, viral or fungal infection requiringsystemic therapy. Patients can be reevaluated for the study if the infection isdeemed 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/socialsituations that would limit compliance with study requirements or could compromisepatient safety.

• Known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis orpneumonitis.

• Pregnant women are excluded from this study because of potential risk forteratogenic or abortifacient effects. Because there is an unknown but potential riskfor adverse events in nursing infants secondary to treatment of the mother withchemotherapy and amplitude-modulated radiofrequency electromagnetic fields, patientswho 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 weeksprior to the treatment day.

• Unable to comply with study procedures or anticipating a situation that would resultin 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 otherinvestigational agents.