Phase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer.

2.50
Hdl Handle:
http://hdl.handle.net/10541/77866
Title:
Phase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer.
Authors:
Danson, Sarah; Ferry, David R; Alakhov, V; Margison, Jennifer M; Kerr, David J; Jowle, Debra; Brampton, M; Halbert, G; Ranson, Malcolm R
Abstract:
SP1049C is a novel anticancer agent containing doxorubicin and two nonionic pluronic block copolymers. In preclinical studies, SP1049C demonstrated increased efficacy compared to doxorubicin. The objectives of this first phase I study were to determine the toxicity profile, dose-limiting toxicity, maximum tolerated dose and pharmacokinetic profile of SP1049C, and to document any antitumour activity. The starting dose was 5 mg m(-2) (doxorubicin content) as an intravenous infusion once every 3 weeks for up to six cycles. A total of 26 patients received 78 courses at seven dose levels. The dose-limiting toxicity was myelosuppression and DLT was reached at 90 mg m(-2). The maximum tolerated dose was 70 mg m(-2) and is recommended for future trials. The pharmacokinetic profile of SP1049C showed a slower clearance than has been reported for conventional doxorubicin. Evidence of antitumour activity was seen in some patients with advanced resistant solid tumours. Phase II trials with this agent are now warranted to further define its antitumour activity and safety profile.
Affiliation:
Department of Medical Oncology, Christie Hospital NHS Trust, Wilmslow Road, Withington, Manchester M20 4BX, UK.
Citation:
Phase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer. 2004, 90 (11):2085-91 Br. J. Cancer
Journal:
British Journal of Cancer
Issue Date:
1-Jun-2004
URI:
http://hdl.handle.net/10541/77866
DOI:
10.1038/sj.bjc.6601856
PubMed ID:
15150584
Type:
Article
Language:
en
ISSN:
0007-0920
Appears in Collections:
All Christie Publications

Full metadata record

DC FieldValue Language
dc.contributor.authorDanson, Sarah-
dc.contributor.authorFerry, David R-
dc.contributor.authorAlakhov, V-
dc.contributor.authorMargison, Jennifer M-
dc.contributor.authorKerr, David J-
dc.contributor.authorJowle, Debra-
dc.contributor.authorBrampton, M-
dc.contributor.authorHalbert, G-
dc.contributor.authorRanson, Malcolm R-
dc.date.accessioned2009-08-19T14:07:41Z-
dc.date.available2009-08-19T14:07:41Z-
dc.date.issued2004-06-01-
dc.identifier.citationPhase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer. 2004, 90 (11):2085-91 Br. J. Canceren
dc.identifier.issn0007-0920-
dc.identifier.pmid15150584-
dc.identifier.doi10.1038/sj.bjc.6601856-
dc.identifier.urihttp://hdl.handle.net/10541/77866-
dc.description.abstractSP1049C is a novel anticancer agent containing doxorubicin and two nonionic pluronic block copolymers. In preclinical studies, SP1049C demonstrated increased efficacy compared to doxorubicin. The objectives of this first phase I study were to determine the toxicity profile, dose-limiting toxicity, maximum tolerated dose and pharmacokinetic profile of SP1049C, and to document any antitumour activity. The starting dose was 5 mg m(-2) (doxorubicin content) as an intravenous infusion once every 3 weeks for up to six cycles. A total of 26 patients received 78 courses at seven dose levels. The dose-limiting toxicity was myelosuppression and DLT was reached at 90 mg m(-2). The maximum tolerated dose was 70 mg m(-2) and is recommended for future trials. The pharmacokinetic profile of SP1049C showed a slower clearance than has been reported for conventional doxorubicin. Evidence of antitumour activity was seen in some patients with advanced resistant solid tumours. Phase II trials with this agent are now warranted to further define its antitumour activity and safety profile.en
dc.language.isoenen
dc.subjectCanceren
dc.subject.meshAdult-
dc.subject.meshAged-
dc.subject.meshAntibiotics, Antineoplastic-
dc.subject.meshDoxorubicin-
dc.subject.meshFemale-
dc.subject.meshHumans-
dc.subject.meshInfusions, Intravenous-
dc.subject.meshMale-
dc.subject.meshMaximum Tolerated Dose-
dc.subject.meshMiddle Aged-
dc.subject.meshNeoplasms-
dc.subject.meshPoloxamer-
dc.subject.meshPolymers-
dc.titlePhase I dose escalation and pharmacokinetic study of pluronic polymer-bound doxorubicin (SP1049C) in patients with advanced cancer.en
dc.typeArticleen
dc.contributor.departmentDepartment of Medical Oncology, Christie Hospital NHS Trust, Wilmslow Road, Withington, Manchester M20 4BX, UK.en
dc.identifier.journalBritish Journal of Canceren

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