| Autor: |
D’Agostino, Giuseppe, Ferrandina, Gabriella, Garganese, Giorgia, Salerno, M. Giovanna, Lorusso, Domenica, Farnetano, M. Giuseppina, Mancuso, Salvatore, Scambia, Giovanni |
| Předmět: |
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| Zdroj: |
Oncology; 2002, Vol. 62 Issue 2, p110-114, 5p, 4 Charts |
| Abstrakt: |
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/m[sup 2] and GEM 600 mg/m[sup 2] . 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.Copyright © 2002 S. Karger AG, Basel [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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