safety & efficacy study of gemcitabine...with high dose iv vit. c (hdivc)

Conditions: Metastatic Adenocarcinoma of the Pancreas

Summary: * the combination of gemcitabine and hdivc is safe and may favorably change the clinical course for an individual patient. * the combination of gemcitabine and hdivc is synergistic in anti-tumor effect as seen in preclinical models, where hdivc creates a pro-oxidative effect that adds to the anti-tumor effect of gemcitabine. * the combination of gemcitabine and hdivc may improve progression free survival (pfs). * the dosage schema of 1.2 g /kg bolus infusion followed by lower dose of 0.3 g / kg infusion may create sustained elevation in vitamin c plasma levels for increased cytotoxic effect. * the addition of hdivc \& oral supplementation of vitamin c to standard treatment with gemcitabine may improve quality of life for patients with comparison to prior to treatment start of this protocol. * ca 19-9 and inflammatory markers may show trends for patients in this trial.


Eligibility criteria:
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 exclusion criteria: * glucose-6-phosphate dehydrogenase deficiency (g6pd) * renal insufficiency : serum creatinine of \> 1.5 mg /dl or evidence of oxalosis by urinalysis prior to enrollment and prior to each hdivc infusion * documentation or report of history of kidney stones or urinary oxalosis. * co-morbid condition that would affect survival: congestive heart failure, unstable angina, myocardial infarction within 6 weeks of study, uncontrolled blood sugars of \> 300 mg / dl, patients with known chronic active hepatitis or cirrhosis * currently active second malignancy * chronic hemodialysis * iron overload/ hemochromatosis: ferritin \> 500 ng / ml * wilson's disease * pregnant or lactating female (pre- menopausal females will undergo pregnancy test prior to administration of protocol drugs throughout treatment cycles during this study) * aspirin use exceeding 81 mg per day * acetaminophen use exceeding 2 g per day * known brain metastasis * active tobacco smokers * treatment with the combination of hdivc and gemcitabine previously