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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Time to event outcome measure (death), measured in days from cycle 1 day 1.
up to 5 years
Joseph J Cullen, MD
The University of Iowa
United States: Food and Drug Administration
|The Holden Comprehensive Cancer Center||Iowa City, Iowa 52242|