NCT00249262

Taxoprexin Treatment for Advanced Skin Melanoma

Phase II Open-Label Study of Weekly Taxoprexin (DHA-paclitaxel) Injection as First Line Treatment of Patients With Metastatic Non-choroidal Melanoma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (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 malignant 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 malignant melanoma who have not received cytotoxic agents for advanced disease. 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 weekly for the first five weeks of a six week cycle.

Timeline

• Start date: 2005-10-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2005-11-07
• Last updated: 2025-09-26