A phase I study of vitamin E, 5-fluorouracil and leucovorin for advanced malignancies

Charles D. Blanke, Michael Stipanov, Jason Morrow, Mace Rothenberg, Rebecca Chinery, Yu Shyr, Robert Coffey, David H. Johnson, Steven D. Leach, R. Daniel Beauchamp

Research output: Contribution to journalArticle

10 Scopus citations

Abstract

Six patients with incurable malignancies were originally treated with vitamin E, 3200 IU/day for fourteen days, followed by the same dose of vitamin E daily plus LCV (20 mg/m2 iv bolus daily × 5) with 5FU (425 mg/m2 iv bolus immediately following LCV). The same schedule of LCV and 5FU was repeated 4 weeks later, then every 5 weeks indefinitely. When 3 of the first 6 had grade 3/4 toxicity, six more patients were treated on the identical drugs and schedule. Seven of twelve total patients had one or more grade 3/4 toxicities. Neutropenia, abdominal pain, and diarrhea were most common. No patient had a documented response, though seven patients did have stable disease. Though the combination of vitamin E and chemotherapy was toxic, this trial demonstrated maximal therapeutic doses of vitamin E can be combined with standard 5FU and LCV, without significantly increasing the side effects of the chemotherapy itself.

Original languageEnglish (US)
Pages (from-to)21-27
Number of pages7
JournalInvestigational New Drugs
Volume19
Issue number1
DOIs
StatePublished - Mar 24 2001

Keywords

  • Antioxidant
  • Chemotherapy

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)

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    Blanke, C. D., Stipanov, M., Morrow, J., Rothenberg, M., Chinery, R., Shyr, Y., Coffey, R., Johnson, D. H., Leach, S. D., & Beauchamp, R. D. (2001). A phase I study of vitamin E, 5-fluorouracil and leucovorin for advanced malignancies. Investigational New Drugs, 19(1), 21-27. https://doi.org/10.1023/A:1006484031959