Clinical Trial of High-dose Vitamin C for Advanced Pancreatic Cancer
Condition: Pancreatic Neoplasms; Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Gemcitabine with escalating ascorbic acid
Intervention description: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)
Intervention MeSH terms: Ascorbic Acid; Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamins; Complementary medicine; Pancreatic cancer; Ascorbate; Ascorbic Acid; Antioxidants; Gemcitabine; Pharmacologic actions

Summary:

      This is a phase II study. It is designed to provide information about if high-dose ascorbate
      (vitamin C) increases survival for pancreatic cancer patients. The hypothesis is that vitamin
      C is well tolerated and increases cancer treatment effectiveness, lengthening survival time
      for patients with advanced pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have a cytological or histological diagnosis of adenocarcinoma arising
             in the pancreas. Diagnosis from metastatic sampling is acceptable.

          -  Disease must be measured radiologically.

          -  Failed initial therapy or ineligible for definitive curative therapy.

          -  If prior treatment included radiation therapy, recurrent disease must be outside of
             the targeted volume.

          -  Age ≥ 18 years

          -  ECOG performance status 0-2 (Karnofsky > 50%, see Appendix A).

          -  Patients must have normal organ and marrow function as defined below:

               -  leukocytes ≥ 3,000/mm3

               -  absolute neutrophil count ≥ 1,500/mm3

               -  platelets ≥ 100,000/mm3

               -  total bilirubin < 2x institutional upper limit of normal

               -  AST(SGOT) < 3x institutional upper limit of normal OR < 5x institutional upper
                  limit of normal for patients presenting with liver metastases

               -  ALT (SGPT) < 3x institutional upper limit of normal OR < 5x institutional upper
                  limit of normal for patients presenting with liver metastases

               -  PT/INR within normal institutional limits, unless patient is on warfarin or other
                  antithrombotic agents

               -  creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance ≥
                  60 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.

               -  Not pregnant. Women of child-bearing potential and men must agree to use adequate
                  contraception (hormonal or barrier method of birth control; abstinence) prior to
                  study entry and for the duration of study participation. Should a woman become
                  pregnant or suspect she is pregnant while participating in this study, she should
                  inform her treating physician immediately.

               -  Ability to understand and the willingness to sign a written informed consent
                  document.

        Exclusion Criteria:

          -  Prior chemotherapy to treat metastatic disease.

          -  Adjuvant therapy (including radiation therapy) within 4 calendar weeks.

          -  Unresolved toxicities from prior therapy for the malignancy.

          -  G6PD (glucose-6-phosphate dehydrogenase) deficiency.

          -  Second malignancy other than non-melanoma skin cancers within the past 5 years.

          -  Excess consumption of alcohol where an excess of alcohol is defined as more than four
             of any one of the following per day: 30 mL distilled spirits, 340 mL beer, or 120 mL
             wine.

          -  Uncontrolled intercurrent illness including, but not limited to ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, psychiatric illness/social situations, or any other condition that would
             limit compliance with study requirements as determined by study team members.

          -  Pregnant or lactating women: The risks of chemotherapy to a fetus/infant are well
             documented.