Robert Beauchamp
Principal Investigator
Last active: 10/31/2018

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

Blanke CD, Stipanov M, Morrow J, Rothenberg M, Chinery R, Shyr Y, Coffey R, Johnson DH, Leach SD, Beauchamp RD
Invest New Drugs. 2001 19 (1): 21-7

PMID: 11291830

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 i.v. bolus daily x 5) with 5FU (425 mg/m2 i.v. 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.

MeSH Terms (18)

Abdominal Pain Adult Aged Antineoplastic Combined Chemotherapy Protocols Diarrhea Dinoprost Dose-Response Relationship, Drug F2-Isoprostanes Female Fluorouracil Humans Infusions, Intravenous Leucovorin Male Middle Aged Neoplasms Neutropenia Vitamin E

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