Taxoprexin Treatment for Advanced Skin Melanoma

Status Completed

Clinical Trial 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.

Clinical Trial 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 IL-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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00249262
Study type	Interventional
Source	Luitpold Pharmaceuticals
Contact
Status	Completed
Phase	Phase 2
Start date	October 2005
Completion date	April 2007

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