Pharmacological Ascorbate for the Control of Metastatic and Node-Positive Pancreatic Cancer (PACMAN): A Phase II Trial

Inclusion Criteria:

- Patients must have a cytological or histological diagnosis of adenocarcinoma arising
in the pancreas. Diagnosis from metastatic sampling is acceptable.

- Disease must be measured radiologically.

- Failed initial therapy or ineligible for definitive curative therapy.

- If prior treatment included radiation therapy, recurrent disease must be outside of
the targeted volume.

- Age ≥ 18 years

- ECOG performance status 0-2 (Karnofsky > 50%, see Appendix A).

- Patients must have normal organ and marrow function as defined below:

- leukocytes ≥ 3,000/mm3

- absolute neutrophil count ≥ 1,500/mm3

- platelets ≥ 100,000/mm3

- total bilirubin < 2x institutional upper limit of normal

- AST(SGOT) < 3x institutional upper limit of normal OR < 5x institutional upper
limit of normal for patients presenting with liver metastases

- ALT (SGPT) < 3x institutional upper limit of normal OR < 5x institutional upper
limit of normal for patients presenting with liver metastases

- PT/INR within normal institutional limits, unless patient is on warfarin
or other antithrombotic agents

- creatinine < 1.5 X institutional upper limit of normal OR creatinine clearance ≥
60 mL/min/1.73 m2 for patients with creatinine levels above institutional
normal.

- Not pregnant. Women of child-bearing potential and men must agree to use
adequate contraception (hormonal or barrier method of birth control; abstinence)
prior to study entry and for the duration of study participation. Should a woman
become pregnant or suspect she is pregnant while participating in this study,
she should inform her treating physician immediately.

- Ability to understand and the willingness to sign a written informed consent
document.

Exclusion Criteria:

- Prior chemotherapy to treat metastatic disease.

- Adjuvant therapy (including radiation therapy) within 4 calendar weeks.

- Unresolved toxicities from prior therapy for the malignancy.

- G6PD (glucose-6-phosphate dehydrogenase) deficiency.

- Second malignancy other than non-melanoma skin cancers within the past 5 years.

- Excess consumption of alcohol where an excess of alcohol is defined as more than four
of any one of the following per day: 30 mL distilled spirits, 340 mL beer, or 120 mL
wine.

- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, psychiatric illness/social situations, or any other condition that would
limit compliance with study requirements as determined by study team members.

- Pregnant or lactating women: The risks of chemotherapy to a fetus/infant are well
documented.