Bevacizumab and Erlotinib or Sorafenib as First-Line Therapy in Treating Patients With Advanced Liver Cancer
- Conditions
- Liver Cancer
- Interventions
- Registration Number
- NCT00881751
- Lead Sponsor
- Medical University of South Carolina
- Brief Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Erlotinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab, erlotinib, and sorafenib may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving bevacizumab together with erlotinib is more effective than giving sorafenib in treating patients with liver cancer.
PURPOSE: This randomized phase II trial is studying how well giving bevacizumab together with erlotinib works compared with sorafenib as first-line therapy in treating patients with advanced liver cancer.
- Detailed Description
OBJECTIVES:
Primary
* To estimate the overall survival in patients with advanced hepatocellular carcinoma treated with bevacizumab and erlotinib hydrochloride vs sorafenib tosylate.
Secondary
* To estimate the event-free survival and tumor response rate of these patients.
* To evaluate the safety and tolerability of these regimens in these patients.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28.
* Arm II: Patients receive oral sorafenib tosylate twice daily on days 1-28. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 30 days and then every 3 months for 1 year.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 95
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm 1: bevacizumab and erlotinib bevacizumab Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Arm 1: bevacizumab and erlotinib erlotinib hydrochloride Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Arm 2: sorafenib tosylate sorafenib tosylate Patients receive oral sorafenib tosylate twice daily on days 1-28.
- Primary Outcome Measures
Name Time Method Overall Survival from date of day 1 until the date of death Overall survival is defined as the time from treatment day 1 until death from any cause. Patients still alive at the end of follow up,patients who withdrew consent from the trial and patients who were lost to follow up will have their survival time censored at the last date of contact.
- Secondary Outcome Measures
Name Time Method Response Rate From day 1 drug administration until 30 days after the last dose of study drug. Secondary outcome measures include response rate as assessed on restaging imaging studies utilizing RECIST 1.1.
Event-free Survival From the time of randomization until progression, withdrawal due to toxicity or any other clinical event requiring withdrawal from the study. EFS is defined as the time from randomization to any of the following three types of events: 1 - progression; 2 - withdrawal due to excessive toxicity; 3 - any other clinical event requiring withdrawal from the study.
Number of SAEs Experienced From day 1 of drug administration until 30 days after the last dose of study drug. The study will report the number of SAEs experienced in each arm. All patients who receive any study drug will be evaluable for toxicity.
Trial Locations
- Locations (6)
UVA Cancer Center
🇺🇸Charlottesville, Virginia, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Tennessee Oncology, PLLCat Sarah Cannon Cancer Center
🇺🇸Nashville, Tennessee, United States
Hollings Cancer Center at Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Columbia University/ New York Presbyterian Hospital
🇺🇸New York, New York, United States
California Pacific Medical Center
🇺🇸San Francisco, California, United States