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Phase I evaluation of intravenous ascorbic Acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer.
Department of Medical Oncology Faculty Papers
  • Daniel A. Monti, MD, Thomas Jefferson University
  • Edith Mitchell, Department of Medical Oncology, Thomas Jefferson University
  • Anthony J Bazzan, Myrna Brind Center of Integrative Medicine, Thomas Jefferson University
  • Susan Littman, Department of Medical Oncology, Thomas Jefferson University
  • George Zabrecky, Myrna Brind Center of Integrative Medicine, Thomas Jefferson University
  • Charles J Yeo, Department of Surgery and the Jefferson Pancreas, Biliary, and Related Cancer Center, Thomas Jefferson University
  • Madhaven V Pillai, Department of Medical Oncology, Thomas Jefferson University
  • Andrew B Newberg, Myrna Brind Center of Integrative Medicine, Thomas Jefferson University
  • Sandeep Deshmukh, Department of Radiology, Thomas Jefferson University
  • Mark Levine, Molecular and Clinical Nutrition Section, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health
Document Type
Article
Publication Date
1-17-2012
Disciplines
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This article has been peer reviewed and is published in PLoS One 2012, 7(1). The published version is available at DOI: 10.1371/journal.pone.0029794. © Public Library of Science

Abstract
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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Creative Commons Attribution 4.0
Citation Information
Daniel A. Monti, MD, Edith Mitchell, Anthony J Bazzan, Susan Littman, et al.. "Phase I evaluation of intravenous ascorbic Acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer." (2012)
Available at: http://works.bepress.com/sandeep_deshmukh/1/