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

Study Overview

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

* 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.

N/A

Metastatic Adenocarcinoma of the Pancreas

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

ERMC 11-11

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2012-07-13	Results First Submitted 2014-11-26	Last Update Submitted that met QC Criteria 2018-07-24
First Submitted that Met QC Criteria 2012-07-30	Results First Submitted that Met QC Criteria 2014-11-26	Last Update Posted (ACTUAL) 2018-07-26
First Posted (ACTUAL) 2012-08-01	Results First Posted 2014-12-01	Last Verified 2018-01

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: HDIVC Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).	DRUG: Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C) Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: HDIVC

Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).

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

Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.

Primary Outcome Measures	Measure Description	Time Frame
Adverse Events as a Measure of Safety and Tolerability	Adverse events, whether volunteered by the study subject, discovered by the investigators during questioning, or detected by physical examination, laboratory tests, or other means will be collected and recorded at each visit. Events will be recorded from the time the consent is signed until 4 weeks after the study protocol is discontinued. Subjects experiencing Grade 4 neutropenia, Grade ≥3 thrombocytopenia, or Grade 2 peripheral neuropathy who do not recover will have treatment protocol discontinued.	Weekly for up to 6 months.

Secondary Outcome Measures	Measure Description	Time Frame
Anti-Tumor Response	CT and PET scans will be performed at baseline and then every two months. Target and Non-Target Lesions will be identified and recorded at baseline. When subsequent scans are performed, anti-tumor responses will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST).	Every 2 months for up to 6 months.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Eiko Klimant, MD, FACP, Eastern Regional Medical Center

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record