NCT00738361

Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery

A Phase 2 Study Of Weekly Infusion Nab-paclitaxel (Paclitaxel Protein-bound Particles for Injectable Suspension) In Patients With Unresectable And Metastatic Uveal Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 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. PURPOSE: This phase II trial is studying how well paclitaxel albumin-stabilized nanoparticle formulation works in treating patients with metastatic melanoma of the eye that cannot be removed by surgery.

Detailed description

OBJECTIVES: Primary * To evaluate the overall response rate of patients with unresectable, metastatic uveal melanoma treated with paclitaxel albumin-stabilized nanoparticle formulation. Secondary * To determine the median progression-free survival of patients treated with this regimen. * To determine the overall survival of patients treated with this regimen. OUTLINE: Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed every 8 weeks for 1 year.

Conditions

• Intraocular Melanoma

Interventions

Type	Name	Description
DRUG	nab-paclitaxel	150 mg/m2 weekly for 3 of 4 weeks every 28 days.

Timeline

• Start date: 2008-08-01
• Primary completion: 2012-07-01
• Completion: 2013-04-01
• First posted: 2008-08-20
• Last updated: 2016-02-12
• Results posted: 2016-02-12

Locations

1 site across 1 country: United States