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

Eastern Regional Medical Center

Status and phase

Terminated

Phase 1

Conditions

Metastatic Adenocarcinoma of the Pancreas

Treatments

Drug: Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)

Study type

Interventional

Funder types

Other

Identifiers

ERMC 11-11

Details and patient eligibility

About

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.

Enrollment

3 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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