NCT00825201

Intraperitoneal Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Advanced Cancer of the Peritoneal Cavity

Phase I Trial of Intraperitoneal Nab-Paclitaxel (Abraxane) in the Treatment of Advanced Malignancies Primarily Confined to the Peritoneal Cavity

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Ovarian Cancer
• Peritoneal Cavity Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	paclitaxel albumin-stabilized nanoparticle formulation	Given IP
OTHER	liquid chromatography	Plasma and peritoneal fluid samples will be collected prior to nab-paclitaxel, at completion of nab-paclitaxel infusion and at hours 1, 2, 4, 6, 8, 12, 24 and 48 following completion of infusion.
OTHER	mass spectrometry	Plasma and peritoneal fluid samples will be collected prior to nab-paclitaxel, at completion of nab-paclitaxel infusion and at hours 1, 2, 4, 6, 8, 12, 24 and 48 following completion of infusion.
OTHER	pharmacological study	Plasma and peritoneal fluid samples will be collected prior to nab-paclitaxel, at completion of nab-paclitaxel infusion and at hours 1, 2, 4, 6, 8, 12, 24 and 48 following completion of infusion.
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2009-01-01
• Primary completion: 2018-01-16
• Completion: 2018-01-16
• First posted: 2009-01-19
• Last updated: 2018-01-19

Locations

2 sites across 1 country: United States