A phase I trial of intraperitoneal sustained-release paclitaxel microspheres (Paclimer) in recurrent ovarian cancer: a Gynecologic Oncology Group study

Gynecologic Oncology
Deborah K ArmstrongHoward H Bailey

Abstract

Paclimer is a biodegradable polymer microsphere formulation containing 10% (w/w) paclitaxel that is designed to provide a sustained-release form of paclitaxel after intraperitoneal (IP) administration. The goals of this phase I study were to determine the maximum tolerated dose (MTD) of IP paclitaxel microspheres and the pharmacology of paclitaxel after IP paclitaxel microsphere administration. Twelve patients with recurrent or persistent ovarian or primary peritoneal carcinoma were treated. After placement of an IP catheter, patients were treated with escalating doses of IP paclitaxel microspheres administered with 2 l of normal saline following premedication. Treatment could be repeated once, 8 weeks after initial treatment. The starting dose was 60 mg/m2 and no intrapatient dose escalation was used. One dose-limiting toxicity consisting of abdominal pain, ileus and bowel obstruction was seen with the second cycle of therapy in one patient who received 900 mg/m2. Patients received up to 1200 mg/m2 without further evidence of dose-limiting toxicities (DLT). The study was discontinued before MTD was defined due to the manufacturer's decision to suspend further clinical development of paclitaxel microspheres. Pharmacokinetic ana...Continue Reading

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