A Phase 2 Trial of High-dose Ascorbate for Pancreatic Cancer (PACMAN 2.1)

Prior treatment

• Prior chemotherapy to treat the metastatic disease
• Other therapy (including radiation) within the past 4 weeks
• Side effects from prior therapies that are still deemed moderate to severe by a physician
• Patients actively receiving insulin or who are currently recommended to receive insulin by a doctor
• Patients who are on the following drugs and cannot have a substitution (or who decline the substitution):
  • warfarin
  • flecainide
  • methadone
  • amphetamines
  • quinidine
  • chlorpropamide

Other illness

• An active cancer, other than the pancreatic cancer, that requires treatment.
• Uncontrolled, intercurrent illness
• HIV positive individuals undergoing therapy due to known drug:drug interaction between antiretroviral drugs and high-dose ascorbate therapy

Lab values

• Glucose-6-phosphate dehydrogenase (G6PD) deficiency
• Patients requiring daily finger-stick blood glucose measurements

Other

• Enrolled in another therapeutic clinical trial
• Women who are nursing

• Pathologic diagnosis (cell samples, biopsy, brushing, surgical sample) of adenocarcinoma of the pancreas. Cancer from the Ampullae of Vater is also eligible. The tissue sample can be from a metastatic location, like a lymph node.
• Metastatic or node positive disease
• One cancer site, that did not receive radiation therapy, that is at least 1 cm in size when looking at it by CT scan (CAT scan)
• Recommended to receive gemcitabine and nab-paclitaxel
• Failed initial therapy or be ineligible for definitive curative therapy (e.g., surgical excision, radiation therapy)
• A platelet count of at least 100,000 cells per mL
• A creatinine level of less than 1 1/2 times the upper limit of normal for the local lab test, or, a creatinine clearance of at least 60 mL/(min\*1.73m2)
• Not pregnant
• Commit to using birth control during the study (all participants)