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).
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)
Joseph J Cullen, M.D.
The University of Iowa
United States: Food and Drug Administration
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