Phase II Open-Label Study of Weekly Taxoprexin® (DHA-paclitaxel) Injection as Second Line Therapy for Patients With Advanced Primary Cancers of the Liver, Including Hepatocellular Carcinoma and Carcinoma of the Gallbladder or Biliary Tract
This is a Phase II open-label study of weekly Taxoprexin® Injection in patients with
advanced primary cancers of the liver, including hepatocellular carcinoma (HCC), or
carcinoma of the gallbladder or biliary tract (BTC), who have not received prior systemic
cytotoxic therapy for advanced disease. Patients may have previously received radiation
and/or systemic chemotherapy as adjuvant therapy. Patients may not have been treated
previously with a taxane. Patients may have been previously treated with up to two
immunological and/or biologic agents (e.g., interferon, monoclonal antibodies, tyrosine
kinase inhibitors). Patients will receive Taxoprexin® Injection at a dose of 500mg/m2
(400mg/m2 for patients with an elevated bilirubin at baseline) 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
Ahmed Kaseb, M.D.
Study Director
M.D. Anderson Cancer Center
United States: Food and Drug Administration
P01-05-23
NCT00422877
January 2007
December 2008
Name | Location |
---|---|
University of Texas, MD Anderson Cancer Center | Houston, Texas 77030 |