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Safety & Efficacy Study of Gemcitabine...With High Dose IV Vit. C (HDIVC) | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

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.

NCT01654861•Eastern Regional Medical Center

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

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
+6 more criteria

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
+4 more criteria

Locations (1)

Eastern Regional Medical Center

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

June 1, 2012

Primary Completion Date

June 1, 2014

Completion Date

June 1, 2014

Last Updated

July 26, 2018

Enrollment

ACTUAL participants

Conditions

Metastatic Adenocarcinoma of the Pancreas

Interventions

Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)

DRUG