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A phase I and pharmacokinetic study of paclitaxel poliglumex and cisplatin in patients with advanced solid tumors.

Abstract：

PURPOSE:Determine the toxicity, maximum tolerated dose (MTD), and pharmacokinetics of paclitaxel poliglumex (PPX; CT-2103) in combination with cisplatin administered every 3 weeks. PATIENTS AND METHODS:Forty-three patients with advanced solid tumors were treated at escalating doses of PPX with a fixed dose of cisplatin at 75 mg/m(2). Conjugated and unconjugated paclitaxel were measured in plasma and urine. Cisplatin, as total platinum content in urine, was also assayed. RESULTS:Dose-limiting toxicities included neutropenia and neuropathy with a cycle 1 MTD of 210 mg/m(2). Conjugated taxanes had a prolonged half-life of >100 h. Nine patients had partial responses, and 19 had stable disease. CONCLUSIONS:PPX is a water-soluble paclitaxel-polymer conjugate with a prolonged half-life and a limited volume of distribution. PPX/cisplatin showed good activity in a refractory patient population; however, cumulative neuropathy was a significant issue at high doses, suggesting that a lower dose may be appropriate for prolonged therapy.

journal_name

Cancer Chemother Pharmacol

journal_title

Cancer chemotherapy and pharmacology

authors

Verschraegen CF,Skubitz K,Daud A,Kudelka AP,Rabinowitz I,Allievi C,Eisenfeld A,Singer JW,Oldham FB

doi

10.1007/s00280-008-0813-8

subject

Has Abstract

pub_date

2009-04-01 00:00:00

pages

903-10

issue

5

eissn

0344-5704

issn

1432-0843

journal_volume

63

pub_type

杂志文章

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