A Clinical Trial Evaluating the Effect of Pharmacological Ascorbate on Radiation Therapy for Pancreatic Cancer Patients

This phase 2 study is designed to determine the efficacy of adding pharmacological ascorbate
(vitamin C) to standard chemoradiation. The ascorbate is infused before, during, and after
the external beam radiation therapy treatment. Each ascorbate infusion is 75 grams (roughly
the same amount of vitamin C from 1,000 oranges).

For patients eligible for this trial, standard treatment for their cancer includes radiation
therapy combined with weekly gemcitabine (a chemotherapy).

Participants will:

- receive pharmacological ascorbate intravenously ascorbate during their daily radiation
therapy treatments. Radiation treatments are given once a day, Monday through Friday.

- have routine doctor's visits and be asked about any side effects they are experiencing.

This is a phase 2 study to determine the effect, if any, adding pharmacological ascorbate
will have on standard therapy for pancreatic cancer. The study will also record any side
effects of adding ascorbate to standard therapy. Once the patient completes radiation, the
ascorbate infusions are also completed. However, the patient will need to return for regular
follow-up care at University of Iowa.

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet ALL of the following
criteria:

- Ability and willingness to provide informed consent (power of attorney and legally
authorized representatives are not accepted for informed consent)

- Stated willingness to comply with all study procedures and availability for duration
of the study

- At least 18 years of age

- Histologic or cytologic diagnosis of pancreatic adenocarcinoma

- Recommended to receive gemcitabine-based chemoradiation

- Good performance status (ECOG of 0, 1, or 2; KPS of > 50)

- No other active malignancy that requires immediate treatment. Low grown concurrent
cancers are acceptable with the appropriate documentation from the treating
oncologists for that additional primary disease.

- Not experiencing an uncontrolled illness such as infection requiring inpatient
admission, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or any other condition that would limit compliance with the study
requirements or unacceptably increase risk to the participant (as determined by study
team members).

- Agree to abstain from alcohol and specified over the counter supplements during study
treatment

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participating
in this study:

- Glucose-6-phosphate dehydrogenase (G6PD) deficiency

- HIV positive individuals requiring anti-retroviral drug therapy (high-dose ascorbate
is known to interact with many of these drugs)

- Platelet count of <100,000 k/mm3

- Prior radiation that would result in field overlap (this will be determined by the
study's radiation oncologist)

- Actively receiving insulin

- Other therapy (including radiation therapy) within 2 calendar weeks of study therapy

- On any of the following drugs and cannot or will not accept a drug substitution:
warfarin, flecainide, methadone, amphetamines, quinidine, and chlorpropamide

- Other investigational agents (PET or SPECT imaging agents are acceptable)

- Other investigational therapy with the intention to treat the disease under study

- Pregnancy

- Individuals declining to use acceptable birth control during the duration of the study

- Lactating women who decline to discontinue breastfeeding their child (women may
withhold breast feeding and resume under the direction of their medical oncologist
after completion of study)