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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.

Phase 1
18 Years
Open (Enrolling)
Metastatic Adenocarcinoma of the Pancreas

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Trial Information

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.

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

- 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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Adverse Events as a Measure of Safety and Tolerability

Outcome Description:

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.

Outcome Time Frame:

Weekly for up to 6 months.

Safety Issue:


Principal Investigator

Eiko Klimant, MD, FACP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Eastern Regional Medical Center


United States: Institutional Review Board

Study ID:

ERMC 11-11



Start Date:

June 2012

Completion Date:

June 2013

Related Keywords:

  • Metastatic Adenocarcinoma of the Pancreas
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



Eastern Regional Medical CenterPhiladelphia, Pennsylvania