Evaluation of the Safety and Efficacy of Standard Dose Gemcitabine Combined With High Dose Intravenous Vitamin C (HDIVC) Treatment for Patients With Metastatic Adenocarcinoma of the Pancreas.
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