title: Phase I evaluation of intravenous ascorbic acid in combination with gemcitabine and erlotinib in patients with metastatic pancreatic cancer.
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.
  
  
  RESULTS
  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.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00954525.
authors.affiliation: Myrna Brind Center of Integrative Medicine, Thomas Jefferson University, Philadelphia, Pennsylvania, United States of America.
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Monti
authors.forename: Edith
authors.initials: E
authors.lastname: Mitchell
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Bazzan
authors.forename: Susan
authors.initials: S
authors.lastname: Littman
authors.forename: George
authors.initials: G
authors.lastname: Zabrecky
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Yeo
authors.forename: Madhaven V
authors.initials: MV
authors.lastname: Pillai
authors.forename: Andrew B
authors.initials: AB
authors.lastname: Newberg
authors.forename: Sandeep
authors.initials: S
authors.lastname: Deshmukh
authors.forename: Mark
authors.initials: M
authors.lastname: Levine
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001205:Ascorbic Acid / Q000008:administration & dosage / Q000009:adverse effects; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D010190:Pancreatic Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011655:Pulmonary Embolism / Q000139:chemically induced; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D011799:Quinazolines; D003841:Deoxycytidine; D000069347:Erlotinib Hydrochloride; D001205:Ascorbic Acid; D000093542:Gemcitabine