In:
Oncology, S. Karger AG, Vol. 62, No. 2 ( 2002), p. 110-114
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 〈 sup 〉 2 〈 /sup 〉 and GEM 600 mg/m 〈 sup 〉 2 〈 /sup 〉 . 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.
Type of Medium:
Online Resource
ISSN:
0030-2414
,
1423-0232
Language:
English
Publisher:
S. Karger AG
Publication Date:
2002
detail.hit.zdb_id:
1483096-6
detail.hit.zdb_id:
250101-6
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