NCT00244816

Taxoprexin® Treatment for Advanced Eye Melanoma

Phase II Open-Label Study of Weekly Taxoprexin® (DHA-paclitaxel) Injection as Treatment of Patients With Metastatic Uveal (Choroidal) Malignant Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 13 Years
• Healthy volunteers: Not accepted

Summary

To evaluate objective response rate and duration of response to weekly Taxoprexin®. To evaluate the safety profile of weekly Taxoprexin® in this patient population. To evaluate overall survival in the same patient population. To evaluate time to disease progression, and the time to treatment failure in patients with metastatic choroidal melanoma being treated with weekly Taxoprexin® Injection.

Detailed description

This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with metastatic choroidal melanoma who may be previously untreated or have received one prior systemic cytotoxic regimen for advanced disease. Patients may not have been treated previously with taxanes. Patients may have been previously treated with immunological agents including interleukin-2 and vaccines. Patients will receive Taxoprexin® Injection at a dose of 500mg/m2 intravenously by 1-hour infusion weekly for the first five weeks of a six week cycle. Treatment will continue until progression of disease, intolerable toxicity, refusal of continued treatment by patient or Investigator decision.

Conditions

• Metastatic Melanoma

Interventions

Type	Name	Description
DRUG	Taxoprexin	Administered by intravenous infusion over 1 hour infusion for 5 consecutive weeks in a 6-weeks cycle.

Timeline

• Start date: 2005-10-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2005-10-27
• Last updated: 2025-10-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study