Safety & Efficacy Study of Gemcitabine...With High Dose IV Vit. C (HDIVC)

Inclusion Criteria

• •Patient ≥ 18 years of age
• •Biopsy proven adenocarcinoma of the pancreas
• •Evidence of metastatic disease
• •Received at least 1 prior chemotherapy treatment regimen with disease progression
• •May have had any prior chemotherapy regimen including any gemcitabine based regimen or FOLFIRINOX
• •May have participated in a prior study protocol
• •May have had prior treatment with HDIVC
• •Anticipated survival of at least 3 months
• •Eastern Cooperative Oncology Group (ECOG) performance status = 0,1, or 2
• •The patient must have screening laboratory: ANC ≥ 1,500/mm3, Hemoglobin \> 8g/dL, Platelets ≥ 100,000/mm3, Total Bilirubin \< 1.5mg/dL, Creatinine ≤ 1.5mg/dL, Transaminases \< 2.5 x upper limit of normal, Urine Uric Acid \< 1.000 mg/d, Urine pH \< 6, Urine microscopic negative for oxalates (if positive, reflex urinary oxalates \< 60mg/d), PT INR ≤ 1.5, unless patient is on full dose warfarin
• •Glucose-6-phosphate dehydrogenase deficiency (G6PD) normal status via blood test The fluorescent spot test is the simplest, most reliable, and most sensitive of the G6PD screening tests
• •Willingness to undergo central line placement and able to manage care of the entry site safely
• •Willingness to adhere to supplemental oral dose regimen of ascorbic acid 500mg taken twice daily
• •All other nutritional supplements would be discontinued for the duration of the trial except for pancreatic enzymes and probiotics
• •Patients must be able to take food orally or have a peg tube for feeding
• •Able to give consent for protocol participation