Phase I evaluation of intravenous ascorbic Acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer.

Authors

Daniel A. Monti, MD, Thomas Jefferson UniversityFollow
Edith Mitchell, Department of Medical Oncology, Thomas Jefferson UniversityFollow
Anthony J Bazzan, Myrna Brind Center of Integrative Medicine, Thomas Jefferson UniversityFollow
Susan Littman, Department of Medical Oncology, Thomas Jefferson UniversityFollow
George Zabrecky, Myrna Brind Center of Integrative Medicine, Thomas Jefferson UniversityFollow
Charles J Yeo, Department of Surgery and the Jefferson Pancreas, Biliary, and Related Cancer Center, Thomas Jefferson UniversityFollow
Madhaven V Pillai, Department of Medical Oncology, Thomas Jefferson UniversityFollow
Andrew B Newberg, Myrna Brind Center of Integrative Medicine, Thomas Jefferson UniversityFollow
Sandeep Deshmukh, Department of Radiology, Thomas Jefferson UniversityFollow
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

Comments

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.

Recommended Citation

Monti, MD, Daniel A.; Mitchell, Edith; Bazzan, Anthony J; Littman, Susan; Zabrecky, George; Yeo, Charles J; Pillai, Madhaven V; Newberg, Andrew B; Deshmukh, Sandeep; and Levine, Mark, "Phase I evaluation of intravenous ascorbic Acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer." (2012). Department of Medical Oncology Faculty Papers. Paper 4.
https://jdc.jefferson.edu/medoncfp/4

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 License.

PubMed ID

22272248