A Research Trial of High Dose Vitamin C and Chemotherapy for Metastatic Pancreatic Cancer

A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer

This study is designed to determine the maximum tolerated dose of vitamin C when given with a standard chemotherapy for people who have metastatic pancreatic cancer.

This is a phase I, dose-escalating study of ascorbic acid (vitamin C) designed to determine the maximum tolerated dose of vitamin C or, if well tolerated, the dose required to obtain a desired ascorbic acid plasma concentration.

Because this is a phase I study, prospective subjects should have advanced disease (i.e., metastasis) and have failed other curative therapies (or, are unable to receive curative therapies due to comorbidities or stage of disease).

Inclusion Criteria:

• Normal G6PD status
• Histologically or cytologically diagnosed pancreatic adenocarcinoma.
• Disease extent documented by CT scan (radiologically measurable disease is not required)
• Ambulatory patient without evidence of spinal cord compression
• No prior chemotherapy for metastatic disease
• Failed curative therapy or patient ineligible for definitive curative therapy
• Completed adjuvant therapy at least 4 weeks prior and recovered from any/all toxicities related to that treatment.
• If post-therapy, must have disease progression since that treatment
• If treated with prior radiation therapy, disease must be outside of the radiation fields
• No currently active second malignancies unless it is a non-melanoma skin cancer
• Women must be non-pregnant and non-lactating
• ECOG performance of 0, 1, or 2
• Granulocytes at least 1,500 / ul
• Platelets at least 100,000 / ul
• Creatinine less than 1.5 mg/dL or clearance of at least 60 mL / min
• Total bilirubin less than 2 times the upper limit of normal
• AST and ALT less than 3 times the upper limit of normal if liver metastases are not present. If liver metastases are present, AST and ALT less than 5 times the upper limit of normal
• PT INR less than 1.5 (unless the patient is on full dose warfarin)
• Patient must be at least 18 years of age
• Patient must be able to understand consent process, the research study, and be able to sign the consent document

Exclusion Criteria:

• A psychiatric disorder by history or examination that would prevent completion of the study
• ECOG performance of 3 or 4
• Co-morbid conditions that affect survival: end stage congestive heart failure, unstable angina, myocardial infarction (within the past 6 weeks), uncontrolled blood sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.
• Consumption of excess alcohol (more than 4 drinks per day) or use of illicit drugs
• Continued sse of over-the-counter antioxidants (supplements like vitamin C and grape seeds)