Taxoprexin® Treatment for Advanced Primary Cancers of the Liver
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00422877|
Recruitment Status : Terminated (Sponsor suspended development of the drug on September 3, 2008.)
First Posted : January 17, 2007
Last Update Posted : May 10, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Cancer of the Liver||Drug: Taxoprexin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||March 2008|
|Actual Study Completion Date :||March 2008|
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.
- Response Rate
- Time to progression
- Time to treatment failure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|