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A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer

Phase 1
18 Years
Open (Enrolling)
Pancreatic Neoplasms

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Trial Information

A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer

This is a phase I, dose-escalating study of ascorbic acid (vitamin C) designed to determine
the maximum tolerated dose of vitamin C or, if well tolerated, the dose required to obtain a
desired ascorbic acid plasma concentration.

Because this is a phase I study, prospective subjects should have advanced disease (i.e.,
metastasis) and have failed other curative therapies (or, are unable to receive curative
therapies due to comorbidities or stage of disease).

Inclusion Criteria:

- Normal G6PD status

- Histologically or cytologically diagnosed pancreatic adenocarcinoma.

- Disease extent documented by CT scan (radiologically measurable disease is not

- Ambulatory patient without evidence of spinal cord compression

- No prior chemotherapy for metastatic disease

- Failed curative therapy or patient ineligible for definitive curative therapy

- Completed adjuvant therapy at least 4 weeks prior and recovered from any/all
toxicities related to that treatment.

- If post-therapy, must have disease progression since that treatment

- If treated with prior radiation therapy, disease must be outside of the radiation

- No currently active second malignancies unless it is a non-melanoma skin cancer

- Women must be non-pregnant and non-lactating

- ECOG performance of 0, 1, or 2

- Granulocytes at least 1,500 / ul

- Platelets at least 100,000 / ul

- Creatinine less than 1.5 mg/dL or clearance of at least 60 mL / min

- Total bilirubin less than 2 times the upper limit of normal

- AST and ALT less than 3 times the upper limit of normal if liver metastases are not
present. If liver metastases are present, AST and ALT less than 5 times the upper
limit of normal

- PT INR less than 1.5 (unless the patient is on full dose warfarin)

- Patient must be at least 18 years of age

- Patient must be able to understand consent process, the research study, and be able
to sign the consent document

Exclusion Criteria:

- A psychiatric disorder by history or examination that would prevent completion of the

- ECOG performance of 3 or 4

- Co-morbid conditions that affect survival: end stage congestive heart failure,
unstable angina, myocardial infarction (within the past 6 weeks), uncontrolled blood
sugars of greater than 300 mg/dL, known chronic active hepatitis or cirrhosis.

- Consumption of excess alcohol (more than 4 drinks per day) or use of illicit drugs

- Continued sse of over-the-counter antioxidants (supplements like vitamin C and grape

Type of Study:


Study Design:

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

Outcome Measure:

Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine)

Outcome Time Frame:


Safety Issue:


Principal Investigator

Joseph J Cullen, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Iowa


United States: Food and Drug Administration

Study ID:




Start Date:

December 2009

Completion Date:

June 2014

Related Keywords:

  • Pancreatic Neoplasms
  • Ascorbic Acid
  • Gemcitabine
  • Neoplasms
  • Pancreatic Neoplasms



The University of Iowa Hospitals & ClinicsIowa City, Iowa  52242