A phase II study of liposomal doxorubicin in recurrent epithelial ovarian carcinoma

Carmela Arcuri, Roberto Sorio, Germana Tognon, Angela Gambino, Simona Scalone, Antonio Lucenti, Orazio Caffo, Francesco Valduga, Emilio Arisi, Enzo Galligioni

Research output: Contribution to journalArticlepeer-review


Background: We conducted a phase II trial to evaluate the efficacy and safety of liposomal formulation of doxorubicin in recurrent ovarian carcinoma patients. Methods: Thirty patients were included in the study after having obtained an informed consent. Their main characteristics were: median age, 64 years (range, 45-80), ECOG performance status 0 in 17 patients (56%), 1 in 11 patients (36%) and 2 in 2 patients (6.6%). Eighteen patients had metastatic disease and 12 locally advanced disease. All patients were pretreated with a platinum-based chemotherapy: 3 were considered refractory to platinum (progression or stable disease), 2 were platinum resistant (relapse 2 every 4 weeks. Results: The overall response rate was 26.6%, with 2 complete responses and 6 partial responses lasting 3.5 months. The incidence of grade 3-4 toxicity was 23.3% for neutropenia, 10% for mucositis and 10% for plantar-palmar erythrodysesthesia. Median survival was 12+ months (range, 2-26+). Conclusions: Liposomal doxorubicin appears to be a moderately active drug in pretreated patients, and its activity seems to be similar to that reported for other active regimens in terms of response rate. The toxicological profile of liposomal doxorubicin suggests that it may be combined with other drugs in the treatment of patients with ovarian cancer.

Original languageEnglish
Pages (from-to)556-561
Number of pages6
Issue number6
Publication statusPublished - Nov 2004


  • Liposomal doxorubicin
  • Ovarian cancer
  • Pegylation
  • Phase II study

ASJC Scopus subject areas

  • Cancer Research


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