Assessing the Efficacy and Safety of IV Vitamin C in Combination With Standard Chemotherapy for Pancreatic Ca
Status:
Terminated
Trial end date:
2016-01-01
Target enrollment:
Participant gender:
Summary
The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA)
plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic
cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic
acid is safe when given with the chemotherapy. This Phase II trial is an initial test of
efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard
chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic
cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line
treatment. The phase I data suggests that ascorbic acid when given in combination with
gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to
better evaluate the response and confirm initial safety data
Phase:
Phase 2
Details
Lead Sponsor:
Thomas Jefferson University
Treatments:
Ascorbic Acid Gemcitabine Molecular Mechanisms of Pharmacological Action Vitamins