Source:http://linkedlifedata.com/resource/pubmed/id/11914595
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rdf:type | |
lifeskim:mentions | |
pubmed:issue |
2
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pubmed:dateCreated |
2002-3-26
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pubmed:abstractText |
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.
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pubmed:language |
eng
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pubmed:journal | |
pubmed:citationSubset |
IM
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pubmed:chemical |
http://linkedlifedata.com/resource/pubmed/chemical/Antibiotics, Antineoplastic,
http://linkedlifedata.com/resource/pubmed/chemical/Antimetabolites, Antineoplastic,
http://linkedlifedata.com/resource/pubmed/chemical/Deoxycytidine,
http://linkedlifedata.com/resource/pubmed/chemical/Doxorubicin,
http://linkedlifedata.com/resource/pubmed/chemical/Hemoglobins,
http://linkedlifedata.com/resource/pubmed/chemical/Liposomes,
http://linkedlifedata.com/resource/pubmed/chemical/gemcitabine
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pubmed:status |
MEDLINE
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pubmed:issn |
0030-2414
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pubmed:author | |
pubmed:copyrightInfo |
Copyright 2002 S. Karger AG, Basel
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pubmed:issnType |
Print
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pubmed:volume |
62
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pubmed:owner |
NLM
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pubmed:authorsComplete |
Y
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pubmed:pagination |
110-4
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pubmed:dateRevised |
2006-4-24
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pubmed:meshHeading |
pubmed-meshheading:11914595-Adult,
pubmed-meshheading:11914595-Aged,
pubmed-meshheading:11914595-Antibiotics, Antineoplastic,
pubmed-meshheading:11914595-Antimetabolites, Antineoplastic,
pubmed-meshheading:11914595-Antineoplastic Combined Chemotherapy Protocols,
pubmed-meshheading:11914595-Blood Platelets,
pubmed-meshheading:11914595-Deoxycytidine,
pubmed-meshheading:11914595-Doxorubicin,
pubmed-meshheading:11914595-Drug Administration Schedule,
pubmed-meshheading:11914595-Female,
pubmed-meshheading:11914595-Hemoglobins,
pubmed-meshheading:11914595-Humans,
pubmed-meshheading:11914595-Infusions, Intravenous,
pubmed-meshheading:11914595-Leukocytes,
pubmed-meshheading:11914595-Liposomes,
pubmed-meshheading:11914595-Middle Aged,
pubmed-meshheading:11914595-Ovarian Neoplasms,
pubmed-meshheading:11914595-Treatment Outcome
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pubmed:year |
2002
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pubmed:articleTitle |
Phase I study of gemcitabine and liposomal doxorubicin in relapsed ovarian cancer.
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pubmed:affiliation |
Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy.
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pubmed:publicationType |
Journal Article,
Clinical Trial,
Clinical Trial, Phase I
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