Phase II Open-Label Study of Weekly Taxoprexin (DHA-Paclitaxel) Injection as First Line Treatment of Patients With Metastatic Non-Choroidal Melanoma
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Agop Bedikian, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration