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

• Status: Terminated
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eastern Regional Medical Center
• Treatments: Ascorbic Acid; Gemcitabine; Pancrelipase; Vitamins

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