Continuous infusion 5-fluorouracil with escalating doses of intermittent cisplatin and etoposide. A phase I study

Cancer. 1991 Dec 1;68(11):2359-62. doi: 10.1002/1097-0142(19911201)68:11<2359::aid-cncr2820681105>3.0.co;2-a.

Abstract

Continuous infusion 5-fluorouracil (CI 5-FU) and the combination of cisplatin (CDDP) plus etoposide (VP-16) have emerged as salvage regimens for metastatic breast carcinoma (MBC). In this study, 18 patients (15 with MBC) were entered into a Phase I study to determine the maximum intermittent doses of CDDP and VP-16 that could be added to 200 mg/m2/d CI 5-FU. The maximum tolerated dose of the combination was 40 mg/m2 of CDDP and 60 mg/m2 of VP-16 weekly for the first 8 weeks and every other week thereafter. The dose-limiting toxicities of the regimen were myelosuppression and thrombocytopenia. Two complete responses (both patients had received no previous chemotherapy) and one partial response were noticed. This regimen at the doses described here is appropriate for Phase II trials as an alternative to doxorubicin-based regimens for MBC.

Publication types

  • Clinical Trial

MeSH terms

  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / administration & dosage*
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Breast Neoplasms / drug therapy*
  • Cisplatin / administration & dosage
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Drug Evaluation
  • Etoposide / administration & dosage
  • Female
  • Fluorouracil / administration & dosage
  • Gastrointestinal Diseases / chemically induced
  • Hematologic Diseases / chemically induced
  • Humans
  • Infusions, Intravenous
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Neoplasms / drug therapy*
  • Stomatitis / chemically induced

Substances

  • Etoposide
  • Cisplatin
  • Fluorouracil