Phase I study of gemcitabine and liposomal doxorubicin in relapsed ovarian cancer

Giuseppe D'Agostino, Gabriella Ferrandina, Giorgia Garganese, M. Giovanna Salerno, Domenica Lorusso, M. Giuseppina Farnetano, Salvatore Mancuso, Giovanni Scambia

Research output: Contribution to journalArticlepeer-review


Twenty-three patients were enrolled in a phase I study conducted to determine the maximum tolerated doses (MTD) of combined liposomal doxorubicin (CAE) and gemcitabine (GEM) in relapsed ovarian cancer patients. A total of 82 courses are evaluable, with a median number of three cycles administered per patient (range 2-8). GEM was administered on days 1 and 8 by 30-min intravenous infusion immediately after CAE given by 60-min intravenous infusion on day 1; cycles were repeated every 21 days. The starting doses were CAE 20 mg/m2 and GEM 600 mg/m2. Following dose levels were 20/800; 20/1,000; 30/800; 30/1,000; 35/800, and 35/1,000 for CAE and GEM, respectively. The MTD was reached at dose level 5, with febrile neutropenia and thrombocytopenia as dose-limiting toxicities. After the MTD, granulocyte-colony stimulating factor was administered in 15% of cycles. Non-hematological toxicity was mild and manageable. All patients are so far evaluable for response. Among them, 5 partial responses (21.7%; 95% confidence interval, CI: 4.9-38.5), 5 disease stabilizations (21.7%, 95% CI: 4.9-38.5) and 13 progressions (56.6%, 95% CI: 36.4-76.8) have been registered. These results warrant further research in a phase II study.

Original languageEnglish
Pages (from-to)110-114
Number of pages5
Issue number2
Publication statusPublished - 2002


  • Doxorubicin, liposomal
  • Gemcitabine
  • Ovarian cancer
  • Phase I study

ASJC Scopus subject areas

  • Cancer Research
  • Oncology


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