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- Title
A Phase I Study of Paclitaxel and Epirubicin, without and with Filgrastim, for the Treatment of Platinum-Resistant Advanced Ovarian Cancer.
- Authors
Lauria, Rossella; Ferrari, Ettore; Tramontana, Sergio; Morabito, Alessandro; Perrone, Francesco; Maffeo, Antonio; Fiorentino, Roberto; Casella, Gennaro; Iodice, Francesco; Ricchi, Paolo; Carlomagno, Chiara; Varriale, Elisa; De Placido, Giuseppe; De Placido, Sabino; Bianco, Angelo Raffaele; Pignata, Sandro
- 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/m[sup 2] ) and epirubicin (starting dose 90 mg/m[sup 2] , 15 mg/m[sup 2] 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/mm[sup 3] 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/m[sup 2] was the MTD for epirubicin without filgrastim. MTD of epirubicin with filgrastim was not reached at 120 mg/m[sup 2] . 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/m[sup 2] and epirubicin at 120 mg/m[sup 2] with filgrastim is a feasible therapy. Grade 4 leukopenia is the dose limiting toxicity using epirubicin at 90 mg/m[sup 2] without filgrastim.
- Subjects
CANCER chemotherapy; OVARIAN cancer; PACLITAXEL; ANTINEOPLASTIC agents; DRUG therapy
- Publication
Oncology, 1999, Vol 56, Issue 4, p267
- ISSN
0030-2414
- Publication type
Article
- DOI
10.1159/000011977