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Annals of Oncology 14:1406-1411, 2003
© 2003 European Society for Medical Oncology

Original Paper

An escalating dose finding study of liposomal doxorubicin and vinorelbine for the treatment of refractory or resistant epithelial ovarian cancer

R. Tambaro1, S. Greggi2, R. V. Iaffaioli1, A. Rossi3, C. Pisano1, L. Manzione3, E. Ferrari1, M. Di Maio1, F. Iodice2, G. Casella2, G. Laurelli2 and S. Pignata1,+

1 Divisione di Oncologia Medica B and 2 Divisione di Ginecologia Oncologica, Istituto Nazionale Tumori, Napoli; 3 Divisione di Oncologia Medica, Osp. S. Carlo-Potenza, Italy

Received 15 January 2003; revised 17 March 2003; accepted 28 April 2003

Background:

The aim of this study was to determine the maximum tolerated dose (MTD) of liposomal doxorubicin (LD)–vinorelbine (V) in patients with refractory or resistant ovarian cancer.

Patients and methods:

Thirty patients were eligible. Seven levels were studied [LD 25–V20 (three patients enrolled); LD 30–V20 (three); LD 35–V20 (three); LD 20–V25 (three); LD 25–V25 (three); LD 30–V25 (10); LD 35–V25 (five)]. LD was given on day 1, while V was given on days 1 and 8 every 21 days. Cohorts of three patients were enrolled at each level, and another three patients were planned, if one dose-limiting toxicity (DLT) was registered.

Results:

DLT was observed in four patients: two febrile neutropenia, one grade 4 thrombocytopenia and one grade 3 palmar-plantar erythrodysesthesia (PPE) at level 7 (LD 35–V25). Thus, liposomal doxorubicin 30 mg/m2 plus vinorelbine 25 mg/m2 was the MTD. The most frequent toxicity was neutropenia. Fifteen patients (50%) experienced grade 3 neutropenia and 10 (33.3%) grade 4 neutropenia. Non-hematological toxicity was mild. Mucositis and PPE were the most frequent toxicities, but in most cases were grade 1. Out of 29 assessable patients, six (20.7%; 95% confidence interval 10%–39%) experienced an objective response, with one complete response.

Conclusions:

In patients with refractory or resistant ovarian cancer, the recommended doses for the combination studied are liposomal doxorubicin 30 mg/m2 (day 1) plus vinorelbine 25 mg/m2 (day 1 and 8). Neutropenia is the most frequent toxicity, while non-hematological toxicity is mild. Substantial activity was recorded and a phase II study is justified.

Key words: liposomal doxorubicin, ovarian cancer, phase I, vinorelbine


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