, Volume 19, Issue 1, pp 21-27

A Phase I Study of Vitamin E, 5-Fluorouracil and Leucovorin for Advanced Malignancies

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Six patients with incurable malignancies wereoriginally treated with vitamin E, 3200 IU/day for fourteendays, followed by the same dose of vitamin E daily plus LCV(20 mg/m2 iv bolus daily × 5) with 5FU (425mg/m2 iv bolus immediately following LCV). The sameschedule of LCV and 5FU was repeated 4 weeks later, then every5 weeks indefinitely. When 3 of the first 6 had grade 3/4toxicity, six more patients were treated on the identicaldrugs and schedule. Seven of twelve total patients had one ormore grade 3/4 toxicities. Neutropenia, abdominal pain, anddiarrhea were most common. No patient had a documentedresponse, though seven patients did have stable disease.Though the combination of vitamin E and chemotherapy wastoxic, this trial demonstrated maximal therapeutic doses ofvitamin E can be combined with standard 5FU and LCV, withoutsignificantly increasing the side effects of thechemotherapy itself.