Phase II Open-Label Study of Weekly Taxoprexin® (DHA-Paclitaxel) Injection as Treatment of Patients With Metastatic Uveal (Choroidal) Malignant Melanoma
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 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Response Rate
Agop Bedikian, MD
Study Director
M.D. Anderson Cancer Center
United States: Food and Drug Administration
P01-04-22
NCT00244816
October 2005
April 2007
Name | Location |
---|---|
MD Anderson Cancer Center | Houston, Texas 77030-4096 |