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dc.contributor.authorWilliamson, Stephen K.
dc.contributor.authorJohnson, Gary A.
dc.contributor.authorMaulhardt, Holly A.
dc.contributor.authorMoore, Kathleen M.
dc.contributor.authorMcMeekin, D. S.
dc.contributor.authorSchulz, Thomas K.
dc.contributor.authorReed, Gregory A.
dc.contributor.authorRoby, Katherine F.
dc.contributor.authorMackay, Christine B.
dc.contributor.authorSmith, Holly J.
dc.contributor.authorWeir, Scott J.
dc.contributor.authorWick, Jo A.
dc.contributor.authorMarkman, Maurie
dc.contributor.authordiZerega, Gere S.
dc.contributor.authorBaltezor, Michael J.
dc.contributor.authorEspinosa, Jahna
dc.contributor.authorDecedue, Charles J.
dc.identifier.citationWilliamson, S.K., Johnson, G.A., Maulhardt, H.A. et al. Cancer Chemother Pharmacol (2015) 75: 1075. doi:10.1007/s00280-015-2737-4en_US
dc.description.abstractPURPOSE: This multicenter, open-label, dose-escalating, phase I study evaluated the safety, tolerability, pharmacokinetics and preliminary tumor response of a nanoparticulate formulation of paclitaxel (Nanotax®) administered intraperitoneally for multiple treatment cycles in patients with solid tumors predominantly confined to the peritoneal cavity for whom no other curative systemic therapy treatment options were available. METHODS: Twenty-one patients with peritoneal malignancies received Nanotax® in a modified dose-escalation approach utilizing an accelerated titration method. All patients enrolled had previously received chemotherapeutics and undergone surgical procedures, including 33 % with optimal debulking. Six doses (50–275 mg/m2) of Cremophor-free Nanotax® were administered intraperitoneally for one to six cycles (every 28 days). RESULTS: Intraperitoneal (IP) administration of Nanotax® did not lead to increases in toxicity over that typically associated with intravenous (IV) paclitaxel. No patient reported ≥Grade 2 neutropenia and/or ≥Grade 3 neurologic toxicities. Grade 3 thrombocytopenia unlikely related to study medication occurred in one patient. The peritoneal concentration–time profile of paclitaxel rose during the 2 days after dosing to peritoneal fluid concentrations 450–2900 times greater than peak plasma drug concentrations and remained elevated through the entire dose cycle. Best response assessments were made in 16/21 patients: Four patients were assessed as stable or had no response and twelve patients had increasing disease. Five of 21 patients with advanced cancers survived longer than 400 days after initiation of Nanotax® IP treatment. CONCLUSIONS: Compared to IV paclitaxel administration, Cremophor-free IP administration of Nanotax® provides higher and prolonged peritoneal paclitaxel levels with minimal systemic exposure and reduced toxicity.en_US
dc.publisherSpringer Verlagen_US
dc.rights© Springer-Verlag Berlin Heidelberg 2015en_US
dc.subjectOvarian canceren_US
dc.subjectPeritoneal malignancyen_US
dc.titleA phase I study of intraperitoneal nanoparticulate paclitaxel (Nanotax®) in patients with peritoneal malignanciesen_US
kusw.kuauthorBaltezor, Michael J.
kusw.kuauthorDecedue, Charles J.
kusw.kudepartmentBiotechnology Innovation and Optimization Centeren_US
kusw.oanotesPer SHERPA/RoMEO 5/31/2017: Author's Pre-print: green tick author can archive pre-print (ie pre-refereeing) Author's Post-print: green tick author can archive post-print (ie final draft post-refereeing) Publisher's Version/PDF: cross author cannot archive publisher's version/PDF General Conditions:

Author's pre-print on pre-print servers such as Author's post-print on author's personal website immediately Author's post-print on any open access repository after 12 months after publication Publisher's version/PDF cannot be used Published source must be acknowledged Must link to publisher version Set phrase to accompany link to published version (see policy) Articles in some journals can be made Open Access on payment of additional charge
kusw.oaversionScholarly/refereed, author accepted manuscripten_US
kusw.oapolicyThis item meets KU Open Access policy criteria.en_US

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