High Dose Ascorbic Acid (AA) + Nanoparticle Paclitaxel Protein Bound + Cisplatin + Gemcitabine (AA NABPLAGEM) in Patients Who Have Metastatic Pancreatic Cancer

Inclusion Criteria:

- Be willing and able to provide written informed consent/assent for the trial.

- Be ≥ 18 years of age on day of signing informed consent.

- Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (with
measurable disease according to RECIST 1.1)

- Have a performance status of 0 or 1 on the ECOG performance scale.

- Demonstrate adequate organ function as defined below in Table 4, all screening labs
should be performed within 21 days of treatment initiation.

- Female participants of childbearing potential should have a negative serum pregnancy
test within 72 hours prior to receiving first dose of study medication.

- Female participants of childbearing potential must be willing to use adequate method
of contraception (as outlined in section 4.4.2) for the duration of the trial through
one month after the last dose of trial treatment.

- Male participants must agree to use adequate contraception (as outlined in section
4.4.2) for the duration of the trial through one month after the last dose of trial
treatment. Note: Abstinence is acceptable if this is the usual lifestyle and preferred
contraception for the participant.

Exclusion Criteria:

- Patients must have received no previous radiotherapy, surgery, chemotherapy or
investigational therapy for the treatment of metastatic disease. Prior treatments in
the adjuvant setting with gemcitabine and/or 5-FU or gemcitabine administered as a
radiation sensitizer are allowed, provided at least 6 months have elapsed since
completion of the last dose and no lingering toxicities are present.

- Palliative surgery and/or radiation treatment less than 4 weeks prior to initiation of
study treatment.

- Exposure to any investigational agent within 4 weeks prior to initiation of study
treatment.

- Patients who need constant use of finger stick blood glucose monitoring for tight
control of their diabetes being that the ascorbic acid causes false low readings of
glucose via that technology (Vasudevan and Hirsch 2014) 39

- Any person with a G6PD deficiency

- History of renal oxalate stones (if type of stone is unknown, need to assess urine
oxalates level if >60mg/dL, then patient is not eligible for the study)

- Patient is taking acetaminophen at any dose or any medication that contains
acetaminophen within 72 hours of first dose of ascorbic acid

- Hypersensitivity to any of the agents proposed for treatment.

- Has a known additional malignancy that is progressing or requires active treatment.
Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the
skin that has undergone potentially curative therapy or in situ cervical cancer.

- Has known active central nervous system (CNS) metastases and/or carcinomatous
meningitis. Patients with previously treated brain metastases may participate provided
they are stable (without evidence of progression by imaging for at least four weeks
prior to the first dose of trial treatment and any neurologic symptoms have returned
to baseline), have no evidence of new or enlarging brain metastases, and are not using
steroids for at least 7 days prior to trial treatment. This exception does not include
carcinomatous meningitis, which is excluded regardless of clinical stability.

- Has an active infection requiring systemic therapy.

- Has a history or current evidence of any condition, therapy, or laboratory abnormality
that might confound the results of the trial, interfere with the patient's
participation for the full duration of the trial, or is not in the best interest of
the patient to participate, in the opinion of the treating investigator. Has known
psychiatric or substance abuse disorders that would interfere with cooperation with
the requirements of the trial.

- For female participants: Is pregnant or breastfeeding, or expecting to conceive within
the projected duration of the trial, starting with the pre-screening or screening
visit through one month after the last dose of trial treatment.

- For male participants: Is expecting to impregnate a sexual partner within the
projected duration of the trial, starting with the pre-screening or screening visit
through one month after the last dose of trial treatment.

- Patients with evidence of iron overload, defined as a transferrin saturation > 45
percent AND serum ferritin > 200 ng/mL (males) or >150 ng/mL (females).

- Current, serious, clinically significant cardiac arrhythmias as determined by the
investigator, or patient receiving a digitalis derivative.