Translation of in Vitro and in Vivo Ascorbate Research Into a New Treatment Option for Pancreatic Cancer: Phase I/IIa Clinical Trial
The purpose of this study is to determine if it is safe to give Vitamin C by the vein at
high doses to people with pancreatic cancer and if Vitamin C interferes with how well the
chemotherapy works on cancer cells. This study will also look at how the body processes of
Vitamin C. This study will also help researchers to learn more about long Vitamin C stays in
the blood stream, and how rapidly it is used by the body.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine safety of combined gemcitabine chemotherapy with IV ascorbate.
This will be accomplished by enrolling up to 14 participants fitting inclusion criteria into the Phase I portion of the trial: 7 participants will be enrolled at the determined dose levels and if no significant adverse event is identified, then 7 additional participants will be enrolled. Safety will be assessed by obtaining the following evaluations: toxicity graded by the NCI CTCAE v 4.0, urinalysis pre- and post-infusion, ECG, basic metabolic panel, bicarbonate (pH surrogate marker), CBC, and osmolality.
Jeanne Drisko, MD
University of Kansas
United States: Food and Drug Administration
|University of Kansas Medical Center||Kansas City, Kansas 66160-7353|