A Phase I Trial of Ascorbic Acid and Gemcitabine for the Treatment of Metastatic Pancreatic Cancer
This is a phase I, dose-escalating study of ascorbic acid (vitamin C) designed to determine
the maximum tolerated dose of vitamin C or, if well tolerated, the dose required to obtain a
desired ascorbic acid plasma concentration.
Because this is a phase I study, prospective subjects should have advanced disease (i.e.,
metastasis) and have failed other curative therapies (or, are unable to receive curative
therapies due to comorbidities or stage of disease).
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine)
weekly
Yes
Joseph J Cullen, M.D.
Principal Investigator
The University of Iowa
United States: Food and Drug Administration
200804753
NCT01049880
December 2009
June 2014
Name | Location |
---|---|
The University of Iowa Hospitals & Clinics | Iowa City, Iowa 52242 |