PHASE-I STUDY OF 5-FLUORODEOXYURIDINE PLUS CYTOSINE-ARABINOSIDE INFUSIONS IN PATIENTS WITH SOLID TUMORS

  • 1 January 1979
    • journal article
    • research article
    • Vol. 63  (8) , 1371-1374
Abstract
A phase I trial was conducted in 30 patients with solid tumors, using infusions of 5-fluorodeoxyuridine (5-FUdR) plus cytosine arabinoside (ara-C). Doses ot 5-FUdR administered over 2 h daily .times. 5 ranged from 0.02-1.0 mg/kg, and these doses immediately preceded a 1-h infusion of ara-C. These schedules were selected because 5-FUdR pretreatment sensitized mouse leukemia L5178Y cells in culture to acute cell death by ara-C. Dose-limiting toxicity was myelosuppression. Based upon results in this study, the recommended dose of 5-FUdR to be used in phase II trials of this combination is 0.04-0.05 mg/kg (1.6-2.0 mg/m2) given prior to ara-C at a dose of 100 mg/m2. Antitumor responses were seen in patients with head and neck cancer, breast carcinoma and carcinoid syndrome.