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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.
Age
19 - No limit years
Sex
ALL
Healthy Volunteers
No
City of Hope Medical Center
Duarte, California, United States
Swedish Medical Center
Seattle, Washington, United States
Start Date
January 1, 2009
Primary Completion Date
January 16, 2018
Completion Date
January 16, 2018
Last Updated
January 19, 2018
27
ACTUAL participants
paclitaxel albumin-stabilized nanoparticle formulation
DRUG
liquid chromatography
OTHER
mass spectrometry
OTHER
pharmacological study
OTHER
laboratory biomarker analysis
OTHER
Lead Sponsor
City of Hope Medical Center
Collaborators
NCT05039801
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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