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

NCT ID: NCT01654861

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-06-30

Brief 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.

Conditions

Metastatic Adenocarcinoma of the Pancreas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HDIVC

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

Group Type: EXPERIMENTAL

Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eastern Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eiko Klimant, MD, FACP

Role: PRINCIPAL_INVESTIGATOR

Eastern Regional Medical Center

Heather Wright, ND, FABNO

Role: PRINCIPAL_INVESTIGATOR

Eastern Regional Medical Center

Locations

Eastern Regional Medical Center

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

ERMC 11-11

Identifier Type: -

Identifier Source: org_study_id