Statements in which the resource exists as a subject.
PredicateObject
rdf:type
lifeskim:mentions
pubmed:issue
2
pubmed:dateCreated
2002-3-26
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.
pubmed:language
eng
pubmed:journal
pubmed:citationSubset
IM
pubmed:chemical
pubmed:status
MEDLINE
pubmed:issn
0030-2414
pubmed:author
pubmed:copyrightInfo
Copyright 2002 S. Karger AG, Basel
pubmed:issnType
Print
pubmed:volume
62
pubmed:owner
NLM
pubmed:authorsComplete
Y
pubmed:pagination
110-4
pubmed:dateRevised
2006-4-24
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
pubmed:year
2002
pubmed:articleTitle
Phase I study of gemcitabine and liposomal doxorubicin in relapsed ovarian cancer.
pubmed:affiliation
Department of Obstetrics and Gynecology, Catholic University of the Sacred Heart, Rome, Italy.
pubmed:publicationType
Journal Article, Clinical Trial, Clinical Trial, Phase I