This study is designed to determine the maximum tolerated dose of vitamin C when given with a standard chemotherapy for people who have 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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic acid, given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbic acid per infusion Week 2: 25 grams ascorbic acid per infusion Week 3: 50 grams ascorbic acid per infusion Week 4: 75 grams ascorbic acid per infusion Week 5: 100 grams ascorbic acid per infusion Ascorbic acid infusion dose is maintained at the level that provides a serum level of 350-400 mg/dL.
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Blood cell counts (neutropenia, thrombocytopenia) and serum chemistries (liver function tests, creatinine)
Time frame: weekly
Plasma ascorbate level (targeted to 350 to 400 mg/dL)
Time frame: Weekly
Survival
Time frame: Ongoing
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