Phase I study of weekly high-dose cisplatin combined with long-term oral etoposide in advanced solid tumors

Ann Oncol. 1995 Feb;6(2):190-2. doi: 10.1093/oxfordjournals.annonc.a059117.

Abstract

Background: In a previous phase I study we showed that single-agent cisplatin can be given weekly for six weeks at a dose of 80 mg/m2/wk. It has been suggested that etoposide has synergistic activity with cisplatin and the drug can be given orally continuously. We therefore performed a phase I study with weekly cisplatin combined with oral etoposide.

Patients and methods: Nineteen patients with metastases of a solid tumor were entered in the study. Cisplatin was administered in hypertonic saline (NaCl 3%). Etoposide was administered as 50-mg capsules.

Results: The starting dose was cisplatin weekly at a dose of 70 mg/m2 for six weeks combined with daily oral etoposide at a dose of 50 mg. At the maximum tolerable dose of cisplatin 75 mg/m2/wk and etoposide 50 mg/m2 daily, leukocytopenia and thrombocytopenia were dose-limiting toxic effects which resulted in frequent treatment delays. Other toxicities were mild. Finally, a dose of cisplatin 70 mg/m2/wk weeks 1-2-3 and weeks 5-6-7 in combination with etoposide 50 mg orally days 1-15 and days 29-43 combined a high median cisplatin dose intensity of 52.5 mg/m2/wk with a good patient tolerance.

Conclusion: It is feasible to administer frequently dosed cisplatin in combination with oral etoposide. Leukocytopenia and thrombocytopenia are dose-limiting toxicities. The schedule will be explored further in phase II studies.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase I

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects
  • Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
  • Bone Marrow Diseases / chemically induced
  • Cisplatin / administration & dosage
  • Combined Modality Therapy
  • Etoposide / administration & dosage
  • Female
  • Humans
  • Male
  • Middle Aged
  • Neoplasm Metastasis
  • Neoplasms / drug therapy*
  • Neoplasms / pathology
  • Neoplasms / therapy
  • Remission Induction
  • Salvage Therapy
  • Treatment Outcome

Substances

  • Etoposide
  • Cisplatin