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

Phase 2
18 Years
Not Enrolling
Pancreatic Neoplasms, Pancreatic Cancer

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Trial Information

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

Adenocarcinoma of the pancreas is the fourth leading cause of cancer death in the United
States and is increasing in incidence; the prognosis remains dismal. We propose to
investigate an entirely new approach, using pharmacological ascorbate, combined with
Gemcitabine, to treat this cancer. Intravenous ascorbate (i.e., ascorbic acid, vitamin C),
but not oral ascorbate, produces high plasma concentrations, which are in the range that can
be cytotoxic to tumor cells. Though ascorbate has been utilized in cancer therapy, few
studies have investigated intravenous deliver of ascorbate. Preliminary studies from our
group have demonstrated that ascorbate induces oxidative stress and cytotoxicity in
pancreatic cancer cells; this cytotoxicity appears to be greater in tumor vs. normal cells.
We hypothesize that production of H2O2 mediates the increased susceptibility of pancreatic
cancer cells to ascorbate-induced metabolic oxidative stress. Gemcitabine is the standard
chemotherapy drug used to treat pancreatic cancer.

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

- 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

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

- 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

Type of Study:


Study Design:

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

Outcome Measure:

Overall survival

Outcome Description:

Time to event outcome measure (death), measured in days from cycle 1 day 1.

Outcome Time Frame:

up to 5 years

Safety Issue:


Principal Investigator

Joseph J Cullen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

The University of Iowa


United States: Food and Drug Administration

Study ID:




Start Date:

September 2012

Completion Date:

July 2016

Related Keywords:

  • Pancreatic Neoplasms
  • Pancreatic Cancer
  • Vitamins
  • Complementary medicine
  • Pancreatic cancer
  • Ascorbate
  • Ascorbic Acid
  • Antioxidants
  • Gemcitabine
  • Pharmacologic actions
  • Neoplasms
  • Pancreatic Neoplasms



The Holden Comprehensive Cancer CenterIowa City, Iowa  52242