Phase I clinical trial of cisplatin given i.v. with 5-fluorouracil and high-dose folinic acid

  • James L. Abbruzzese
  • Robert Amato
  • Susan Schmidt
  • Martin N. Raber
  • Philip Frost


We report the results of a phase I study of intravenously administered cisplatin, 5-fluorouracil and high-dose folinic acid. This trial was designed to exploit potential biochemical interactions between these three agents. The maximum tolerated doses were cisplatin, 75 mg/m2, day 1; 5-fluorouracil, 375 mg/m2, days 1–5 and leucovorin 500 mg/m2, days 1–5. The dose-limiting toxic effect of this regimen was myelosuppression. Mild non-hematologic toxic effects were also observed and included nausea, vomiting, stomatitis, and diarrhea. Phase II trial of this regimen are underway, however randomized studies will eventually be necessary to establish whether cisplatin contributes clinically significant activity to this regimen.


Clin Oncol CDDP Leucovorin Refractory Metastatic Breast Cancer A2780 Human Ovarian Cancer Cell 
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Copyright information

© Springer-Verlag 1990

Authors and Affiliations

  • James L. Abbruzzese
    • 1
  • Robert Amato
    • 1
  • Susan Schmidt
    • 1
  • Martin N. Raber
    • 1
  • Philip Frost
    • 1
  1. 1.Department of Medical Oncology, Division of MedicineThe University of Texas M. D. Anderson Cancer CenterHoustonUSA

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