Phase I Trial of Intraperitoneal Nab-Paclitaxel (Abraxane) in the Treatment of Advanced Malignancies Primarily Confined to 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: 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.
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose
28 days following the first course of treatment in which 2 or more patients experience a Dose Limiting Toxicity
Yes
Mihaela Cristea, MD
Principal Investigator
Beckman Research Institute
United States: Institutional Review Board
08059
NCT00825201
December 2008
Name | Location |
---|---|
City of Hope Medical Center | Duarte, California 91010 |
Swedish Medical Center | Seattle, Washington 98122-4307 |