A phase I study of paclitaxel and epirubicin, without and with filgrastim, for the treatment of platinum-resistant advanced ovarian cancer

Rossella Lauria, Ettore Ferrari, Sergio Tramontana, Alessandro Morabito, Francesco Perrone, Antonio Maffeo, Roberto Fiorentino, Gennaro Casella, Francesco Iodice, Paolo Ricchi, Chiara Carlomagno, Elisa Varriale, Giuseppe De Placido, Sabino De Placido, Angelo Raffaele Bianco, Sandro Pignata

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Abstract

The aim of the study was to determine the maximum tolerated dose (MTD) of epirubicin combined with a fixed dose of paclitaxel, without and with support of filgrastim, in patients with platinum resistant or refractory ovarian cancer. Paclitaxel (150 mg/m2) and epirubicin (starting dose 90 mg/m2, 15 mg/m2 escalation per level) were given on day 1, every 28 days for 4-6 cycles. Filgrastim (F) (5 μg/kg/die) was given in case of grade 4 leukopenia (levels without support) or from day 4 up to leukocyte count > 10,000/mm3 after nadir (levels with support). Cohorts of 3 patients were enrolled at each level and further 3 patients were planned if 1 or 2 unacceptable toxic events (UTE) were registered. MTD was determined first without and then with filgrastim. Four levels were studied (90, 90+F, 105+F, 120+F) with 4, 6, 5 and 4 patients enrolled, respectively. UTE (grade 4 neutropenia) were observed in 3 patients at level 1. Thus, 90 mg/m2 was the MTD for epirubicin without filgrastim. MTD of epirubicin with filgrastim was not reached at 120 mg/m2. Hematological toxicity was mild. Grade 3 mucositis was reported in 1 patient. Among the 14 patients with measurable or evaluable disease, 3 objective responses were observed (1 complete and 2 partial) for an overall response rate of 21.4%. The combination of paclitaxel 150 mg/m2 and epirubicin at 120 mg/m2 with filgrastim is a feasible therapy. Grade 4 leukopenia is the dose limiting toxicity using epirubicin at 90 mg/m2 without filgrastim.

Original languageEnglish
Pages (from-to)267-273
Number of pages7
JournalOncology
Volume56
Issue number4
DOIs
Publication statusPublished - May 1999

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Keywords

  • Chemotherapy
  • Ovarian cancer
  • Second-line

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Lauria, R., Ferrari, E., Tramontana, S., Morabito, A., Perrone, F., Maffeo, A., Fiorentino, R., Casella, G., Iodice, F., Ricchi, P., Carlomagno, C., Varriale, E., De Placido, G., De Placido, S., Bianco, A. R., & Pignata, S. (1999). A phase I study of paclitaxel and epirubicin, without and with filgrastim, for the treatment of platinum-resistant advanced ovarian cancer. Oncology, 56(4), 267-273. https://doi.org/10.1159/000011977