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Translation of in Vitro and in Vivo Ascorbate Research Into a New Treatment Option for Pancreatic Cancer: Phase I/IIa Clinical Trial

Phase 1
21 Years
Open (Enrolling)
Pancreatic Cancer

Thank you

Trial Information

Translation of in Vitro and in Vivo Ascorbate Research Into a New Treatment Option for Pancreatic Cancer: Phase I/IIa Clinical Trial

The purpose of this study is to determine if it is safe to give Vitamin C by the vein at
high doses to people with pancreatic cancer and if Vitamin C interferes with how well the
chemotherapy works on cancer cells. This study will also look at how the body processes of
Vitamin C. This study will also help researchers to learn more about long Vitamin C stays in
the blood stream, and how rapidly it is used by the body.

Inclusion Criteria:

- Patients must be 21 years of age or older and have histologically or cytologically
diagnosed carcinoma of the pancreas defined as locally advanced or metastatic and if
locally advanced, not eligible for surgical resection

- The patient must screened for eligibility and have care approved by treating
oncologist; the oncology care is to be dictated by the oncology team and patient and
will include gemcitabine chemotherapy.

- ECOG Performance Status 0-2 Eastern Cooperative Oncology Group Performance Status
Grade 0 = Fully active, able to carry on all pre-disease activities without
restriction Grade 1= Restricted in physical strenuous activity but ambulatory and
able to carry out work of a light or sedentary nature e.g. light housework, office
work Grade 2 = Ambulatory and capable of all self care but unable to carry out any
work activities, up and about more than 50% of waking hours

- Laboratory: ANC ≥1,500/mm3, Hemoglobin > 8g/dL, platelet ≥ 1000,000/mm3, total
bilirubin ≤ 1.5 mg/dL (in the absence of neoplastic involvement), creatinine ≤2.0
mg/dL, transaminase (AST/ALT) ≤2.5X upper limit, urine uric acid < 1,000mg/d, urine
pH <6, urine oxalate <60 mg/d.

- Patients who have no language barrier, are cooperative, and can give informed consent
before entering the study after being informed of the medications and procedures to
be used in this study may participate.

Exclusion Criteria:

- Glucose-6-phosphate-dehydrogenase (G6PD) deficiency

- History of oxalate renal calculi; urine oxalate level > 60 mg/d at baseline

- History of bleeding disorder, iron overload or hemochromatosis

- Prior chemotherapy or currently receiving chemotherapy or radiation therapy or
enrolled in other trials currently or in the preceding 1 month.

- Patients with evidence of a significant psychiatric disorder by history/examination
that would prevent completion of the study will not be allowed to participate.

- ECOG Performance Status of 3-4. Grade 3 = capable of only limited self care, confined
to bed or chair more than 50% of waking hours. Grade 4 = completely disabled. Cannot
carry on any self care. Totally confined to bed or chair.)

- Co-morbid condition that would affect survival: end stage congestive heart failure,
unstable angina, myocardial infarction within 6 weeks of study, uncontrolled blood
sugars ≥ 300 mg/dL, patients with known chronic active hepatitis or cirrhosis.

- Patients who consume an excess of alcohol or abuse drugs (an excess of alcohol is
defined as more than four of any one of the following per day: 30mL distilled
spirits, 340mL beer, or 120mL wine) will not be allowed.

- Patients who smoke tobacco products will not be allowed to participate.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine safety of combined gemcitabine chemotherapy with IV ascorbate.

Outcome Description:

This will be accomplished by enrolling up to 14 participants fitting inclusion criteria into the Phase I portion of the trial: 7 participants will be enrolled at the determined dose levels and if no significant adverse event is identified, then 7 additional participants will be enrolled. Safety will be assessed by obtaining the following evaluations: toxicity graded by the NCI CTCAE v 4.0, urinalysis pre- and post-infusion, ECG, basic metabolic panel, bicarbonate (pH surrogate marker), CBC, and osmolality.

Outcome Time Frame:

12 months

Safety Issue:


Principal Investigator

Jeanne Drisko, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas


United States: Food and Drug Administration

Study ID:




Start Date:

April 2011

Completion Date:

December 2013

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms



University of Kansas Medical Center Kansas City, Kansas  66160-7353