Ovarian Cancer Clinical Trial
Official title:
Phase I Trial of Intraperitoneal Nab-Paclitaxel (Abraxane) in the Treatment of Advanced Malignancies Primarily Confined to the Peritoneal Cavity
RATIONALE: Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle
formulation, work in different ways to stop the growth of tumor cells, either by killing the
cells or by stopping them from dividing. Giving paclitaxel albumin-stabilized nanoparticle
formulation directly into the abdomen may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of intraperitoneal
paclitaxel albumin-stabilized nanoparticle formulation in treating patients with advanced
cancer of the peritoneal cavity.
PRIMARY OBJECTIVES: I. To determine the maximally tolerated dose (MTD) of nab-paclitaxel as a
single agent administered intraperitoneally via an intraperitoneal catheter.
SECONDARY OBJECTIVES: I. To evaluate the pharmacokinetics of nab-paclitaxel (Abraxane) in the
plasma and peritoneum when it is administered directly into the peritoneal cavity. II. To
determine the potential pharmacokinetic advantage (favorable ratio of nab-paclitaxel
(Abraxane) concentration in the peritoneal cavity vs. plasma) for nab-paclitaxel administered
intraperitoneally. III. To determine the progression of peripheral neuropathy in patients
treated with intraperitoneal chemotherapy on this study through pre-treatment and sequential
evaluation of the Neuropathic Pain Syndrome Inventory and Serial Nerve Conduction Studies.
OUTLINE: This is a dose-escalation study. Patients receive paclitaxel albumin-stabilized
nanoparticle formulation given intraperitoneally (IP) on days 1, 8, and 15. Courses repeat
every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
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