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

Oncology
Giuseppe D'AgostinoGiovanni Scambia

Abstract

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(2) and GEM 600 mg/m(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.

Citations

Mar 22, 2003·Gynecologic Oncology·Giuseppe D'AgostinoIgnace Vergote
Oct 31, 2003·Critical Reviews in Oncology/hematology·Erika FruscellaGiovanni Scambia
Feb 1, 2011·American Journal of Clinical Oncology·Jean-Philippe JacquinNicolas Magné
Dec 14, 2005·International Journal of Gynecological Cancer : Official Journal of the International Gynecological Cancer Society·D LorussoG Scambia
Feb 1, 2006·International Journal of Gynecological Cancer : Official Journal of the International Gynecological Cancer Society·D GalloG Scambia
May 1, 2007·Women's Health·Fadi Abushahin, Peter G Rose
Feb 19, 2005·Seminars in Oncology·David S AlbertsAlberto A Gabizon
Feb 4, 2005·Journal of Chemotherapy·D LorussoG Scambia
Aug 30, 2003·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Edgardo RiveraGabriel N Hortobagyi
Dec 14, 2011·Expert Review of Anticancer Therapy·Joseph A RakowskiRobert W Holloway

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