A Phase 2 Study Of Weekly Infusion Nab-paclitaxel (Paclitaxel Protein-bound Particles for Injectable Suspension) In Patients With Unresectable And Metastatic Uveal Melanoma
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.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall response rate
up to 1 year following last treatment
No
Thomas E. Olencki, DO
Principal Investigator
Ohio State University Comprehensive Cancer Center
United States: Institutional Review Board
OSU-08076
NCT00738361
August 2008
Name | Location |
---|---|
Ohio State University Comprehensive Cancer Center | Columbus, Ohio |