Paclitaxel by 72-hour continuous infusion followed by bolus intravenous ifosfamide or epirubicin: Results of two phase I studies

L. Miglietta, C. Marenghi, R. Nizzo, G. Foglia, N. Ragni, Francesco Boccardo

Research output: Contribution to journalArticle

Abstract

Study Purposes: To determine the maximum-tolerated dose (MTD) of paclitaxel administered by 72-hour continuous infusion followed by bolus intravenous ifosfamide on days 4 and 5 or epirubicin on day 4, every 21 days. To assess the toxicity and preliminary activity in patients with advanced refractory solid tumors. Patients and Methods: Sixteen patients with progressive disease after standard chemotherapy for advanced disease were treated with the combination paclitaxel-ifosfamide and 10 patients with the combination paclitaxel-epirubicin. Results: In the first phase I study the MTDs were: paclitaxel 135 mg/m 2 and ifosfamide 2.5 mg/m 2/day; hematologic toxicity was the dose-limiting toxicity (DLT) during the first cycle of therapy at dose level 4. Paclitaxel administered at 135 mg/m 2 and epirubicin 50 mg/m 2 were the MTDs in the second phase I study; grade 4 stomatitis was the DLT of this combination. Conclusions: Paclitaxel by 72-hour continuous infusion followed by bolus ifosfamide was a manageable regimen with an acceptable hematologic toxicity in the absence of neurotoxicity. Preliminary activity of this combination was encouraging in a group of patients with ovarian cancer. The optimal way to combine paclitaxel and epirubicin and the best schedule relative to such a long paclitaxel infusion time in this combination regimen remain to be determined.

Original languageEnglish
Pages (from-to)116-122
Number of pages7
JournalOncology
Volume60
Issue number2
DOIs
Publication statusPublished - 2001

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Keywords

  • Epirubicin
  • Ifosfamide
  • Infusion, continuous
  • Paclitaxel
  • Phase I

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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