Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca

This is an interventional treatment trial for Stage IV Pancreatic Cancer focused on measuring Pancreatic Neoplasms, Pancreatic Cancer cells, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Endocrine Gland Neoplasms, Digestive System Diseases, Pancreatic Diseases, Endocrine System Diseases, Ascorbic Acid, Gemcitabine Vitamins, Vitamin C, Antioxidants, Molecular Mechanisms of Pharmacological Action, Pharmacologic Actions, Protective Agents, Physiological Effects of Drugs, Micronutrients, Growth Substances, Erlotinib, Integrative Medicine, Alternative Medicine, Complementary Medicine Read More

Inclusion Criteria:

• Males and females of age ≥ 18
• Histologically or cytologically confirmed pancreatic adenocarcinoma that has metastatic disease measurable by CT, MRI, or PET
• Subjects with unresectable pancreatic cancer who have had surgery (exploratory laparotomy, biliary, gastrointestinal bypass) are eligible, if the subject has fully recovered from surgery and ≥ 14 days has passed since the operation. Patients with history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence.
• ECOG performance status 0-2
• Laboratory values that would not prevent the patient from receiving chemotherapy as determined by the PI or study oncologist
• G6PD status ≥ lower limit of normal
• Serum creatinine ≤ 2.0 mg/dL

Exclusion Criteria:

• Islet cell or acinar cell carcinoma or cystadenocarcinoma
• History or known presence of central nervous system (CNS) metastases
• History of another primary cancer, except:
• Curatively treated cervical carcinoma in situ, or
• Curatively resected non-melanomatous skin cancer, or
• Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 3 years prior to enrollment
• Other concurrent anticancer chemotherapy
• Prior radiotherapy ≤ 14 days, or if subjects have not recovered from radiotherapy
• Uncontrolled seizure disorder or other serious neurological diseases
• Any co-morbid disease that would increase risk of toxicity as determined by PI
• Only locally advanced disease
• Prior treatment with gemcitabine (for metastatic pancreatic cancer)
• Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids)
• Recent infection requiring a course of systemic anti-infection that was completed ≤ 14 days prior to enrollment (exception can be made at the judgment of the PI for oral treatment of an uncomplicated urinary tract infection ([UTI])
• History of any medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the PI, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study requirements
• Subject unwilling or unable to comply with study requirements
• Subject who is pregnant or breast feeding
• Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection
• Documented history of alcohol, cocaine or intravenous drug abuse ≤ 6 months of enrollment