Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca
Condition: Stage IV Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Ascorbic Acid
Intervention description: 3x per week
Intervention MeSH terms: Ascorbic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: 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

Summary:

      The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA)
      plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic
      cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic
      acid is safe when given with the chemotherapy. This Phase II trial is an initial test of
      efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard
      chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic
      cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line
      treatment. The phase I data suggests that ascorbic acid when given in combination with
      gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to
      better evaluate the response and confirm initial safety data
    

Eligibility criteria:

        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