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