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

Claire F. Verschraegen, Keith Skubitz, Adil Daud, Andrzej P. Kudelka, Ian Rabinowitz, Cecilia Allievi, Amy Eisenfeld, Jack W. Singer, Fred B. Oldham

Research output: Contribution to journalArticlepeer-review

33 Scopus citations

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/m2. 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/m2. 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.

Original languageEnglish (US)
Pages (from-to)903-910
Number of pages8
JournalCancer chemotherapy and pharmacology
Volume63
Issue number5
DOIs
StatePublished - Apr 2009

Keywords

  • Chemotherapy
  • Cisplatin
  • Conjugated taxanes
  • Neuropathy
  • PPX
  • Paclitaxel poliglumex

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