[HTML][HTML] Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer

DA Monti, E Mitchell, AJ Bazzan, S Littman… - PloS one, 2012 - journals.plos.org
DA Monti, E Mitchell, AJ Bazzan, S Littman, G Zabrecky, CJ Yeo, MV Pillai, AB Newberg…
PloS one, 2012journals.plos.org
Background Preclinical data support further investigation of ascorbic acid in pancreatic
cancer. There are currently insufficient safety data in human subjects, particularly when
ascorbic acid is combined with chemotherapy. Methods and Findings 14 subjects with
metastatic stage IV pancreatic cancer were recruited to receive an eight week cycle of
intravenous ascorbic acid (three infusions per week), using a dose escalation design, along
with standard treatment of gemcitabine and erlotinib. Of 14 recruited subjects enrolled, nine …
Background
Preclinical data support further investigation of ascorbic acid in pancreatic cancer. There are currently insufficient safety data in human subjects, particularly when ascorbic acid is combined with chemotherapy.
Methods and Findings
14 subjects with metastatic stage IV pancreatic cancer were recruited to receive an eight week cycle of intravenous ascorbic acid (three infusions per week), using a dose escalation design, along with standard treatment of gemcitabine and erlotinib. Of 14 recruited subjects enrolled, nine completed the study (three in each dosage tier). There were fifteen non-serious adverse events and eight serious adverse events, all likely related to progression of disease or treatment with gemcitabine or erlotinib. Applying RECIST 1.0 criteria, seven of the nine subjects had stable disease while the other two had progressive disease.
Conclusions
These initial safety data do not reveal increased toxicity with the addition of ascorbic acid to gemcitabine and erlotinib in pancreatic cancer patients. This, combined with the observed response to treatment, suggests the need for a phase II study of longer duration.
Trial Registration
Clinicaltrials.gov NCT00954525
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