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

Intraocular Melanoma Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intraocular Melanoma
• Melanoma
• Uveal Neoplasms

• NCT number: NCT00738361
• Study type: Interventional
• Source: Ohio State University Comprehensive Cancer Center
• Status: Completed
• Phase: Phase 2
• Start date: August 2008
• Completion date: April 2013