Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Eastern Regional Medical Center
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
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
Clareo Health | Safety & Efficacy Study of Gemcitabine...With High Dose IV Vit. C (HDIVC)
