Erlotinib Plus Bevacizumab in Hepatocellular Carcinoma (HCC) as Second-line Therapy
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|ClinicalTrials.gov Identifier: NCT01180959|
Recruitment Status : Active, not recruiting
First Posted : August 12, 2010
Last Update Posted : January 14, 2021
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer||Drug: Bevacizumab Drug: Erlotinib||Phase 2|
|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 14, 2011|
|Estimated Primary Completion Date :||May 1, 2021|
|Estimated Study Completion Date :||May 1, 2022|
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|