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

This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring metastatic pancreatic cancer, cancer, pancreatic, Vitamin C, Ascorbic Acid, Nanoparticle Paclitaxel Protein Bound, cisplatin, gemcitabine, pancreas Read More

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic pancreatic adenocarcinoma (with measurable disease according to RECIST 1.1 criteria).
• Adequate organ function.
• Have a performance status of 0 or 1 on the ECOG performance scale.
• 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 for the duration of the trial through one month after the last dose of trial treatment.
• Male participants must agree to use adequate contraception for the duration of the trial through one month after the last dose of trial treatment.

Exclusion Criteria:

• Patients must have received no previous radiotherapy, surgery, chemotherapy or investigational therapy for the treatment of metastatic disease. Only the following prior treatments in the adjuvant setting are permitted: gemcitabine and/or 5-FU or capecitabine or gemcitabine administered as a radiation sensitizer provided at least six months have elapsed since completion of the last dose and no lingering toxicities are present.
• Palliative surgery less than four weeks prior to initiation of study treatment.
• Exposure to any investigational agent within four 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.
• 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 prescreening 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 prescreening 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.