Taxoprexin® Treatment for Advanced Primary Cancers of the Liver
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 primary liver cancer being treated with weekly Taxoprexin® Injection.
To explore the trough and peak blood levels of Taxoprexin® and paclitaxel in these patients.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||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|
- Response Rate
- Time to progression
- Time to treatment failure
|Study Start Date:||January 2007|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Starting dose of 500 mg/m2 (400 mg/m2 for patients with an elevated bilirubin at baseline) administered intravenously by a 1-hour infusion weekly for the first 5 weeks of a 6 week cycle.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422877
|United States, Texas|
|University of Texas, MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Director:||Ahmed Kaseb, M.D.||M.D. Anderson Cancer Center|