Erlotinib Plus Bevacizumab in Hepatocellular Carcinoma (HCC) as Second-line Therapy
|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: NCT01180959|
Recruitment Status : Active, not recruiting
First Posted : August 12, 2010
Last Update Posted : October 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: Bevacizumab Drug: Erlotinib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Erlotinib Plus Bevacizumab in Advanced Hepatocellular Carcinoma as a Second-line Therapy in Patients Who Have Received First-line Sorafenib Therapy (AVF4572)|
|Actual Study Start Date :||April 2011|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2020|
Experimental: Erlotinib + Bevacizumab
Erlotinib 150 mg by mouth once a day. Bevacizumab 10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes.
10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes
150 mg by mouth once a day.
- Number of Patients with Progression Free Survival (PFS) at 16 weeks [ Time Frame: 16 weeks ]Progression-free survival is defined as time from initiation of therapy until documented disease progression or death.
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): NCT01180959
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ahmed Kaseb, MBBS||M.D. Anderson Cancer Center|