Ovarian Cancer Clinical Trial
Official title:
A Phase I Open Label Assessment of the Safety and Pharmacokinetics of Intraperitoneal PACLIMER Microspheres (Polilactofate/Paclitaxel) in Patients With Ovarian Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of paclitaxel in treating patients who
have recurrent or persistent ovarian or primary peritoneal cancer.
OBJECTIVES: I. Determine the safety and tolerability of intraperitoneal administration of
paclitaxel (Paclimer microspheres) in patients with recurrent or persistent ovarian or
primary peritoneal carcinoma. II. Determine and confirm the maximum tolerated dose of this
regimen in this patient population. III. Determine plasma paclitaxel concentrations at
selected times after intraperitoneal administration of Paclimer microspheres in these
patients.
OUTLINE: This is a dose escalation study. Patients receive intraperitoneal paclitaxel
(Paclimer microspheres) every 8 weeks for 2 courses. Cohorts of 1-3 patients receive
escalating doses of intraperitoneal paclitaxel (Paclimer microspheres) until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
of 3 patients experience dose limiting toxicities. Once the probable MTD is determined, an
additional cohort of 8 patients is accrued to confirm the MTD. The MTD is confirmed as the
dose level at which at least 6 of 8 patients demonstrate acceptable safety and tolerability.
PROJECTED ACCRUAL: A maximum of 24 patients will be accrued for this study.
;
Primary Purpose: Treatment
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