Bevacizumab and Erlotinib or Sorafenib as First-Line Therapy in Treating Patients With Advanced Liver Cancer
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.
Drug: erlotinib hydrochloride
Drug: sorafenib tosylate
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Open-Label Multi-Institution Phase II Study of the Combination of Bevacizumab and Erlotinib Compared to Sorafenib in the First-Line Treatment of Patients With Advanced Hepatocellular Carcinoma (HCC)|
- Efficacy [ Time Frame: 28 day cycle ] [ Designated as safety issue: No ]The primary objective of this study is to estimate clinical efficacy outcomes (based on OS) of patients treated with B+E and patients treated with S. Forty-five patients in each arm who are evaluable for response will be sufficient for this analysis. A patient is evaluable for response if one 28-day cycle of therapy is completed. Enrolled patients who are not evaluable will be replaced, so there will be 45 patients in each arm evaluable for response.
- Event-free survival and response rate [ Time Frame: At various points throughout the study duration ] [ Designated as safety issue: No ]Secondary outcome measures include event-free survival and response rate as assessed on restaging imaging studies utilizing RECIST 1.1.
- safety and tolerability [ Time Frame: At various points throught the study duration ] [ Designated as safety issue: Yes ]The study will compare (secondary endpoint) the safety and tolerability of B+E vs S. All patients who receive any study drug will be evaluable for toxicity.
|Study Start Date:||March 2009|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Experimental: 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.
Given IVDrug: erlotinib hydrochloride
Active Comparator: Arm II
Patients receive oral sorafenib tosylate twice daily on days 1-28.
Drug: sorafenib tosylate
- To estimate the overall survival in patients with advanced hepatocellular carcinoma treated with bevacizumab and erlotinib hydrochloride vs sorafenib tosylate.
- 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.
|Contact: Alan Brisendine, CCRP||(843) email@example.com|
|United States, California|
|USC/Norris Comprehensive Cancer Center and Hospital||Recruiting|
|Los Angeles, California, United States, 90033-0804|
|Contact: Anthony B. El-Khoueiry, MD 323-865-3967 firstname.lastname@example.org|
|California Pacific Medical Center||Recruiting|
|San Francisco, California, United States, 94115|
|Contact: Ari Baron, MD 415-923-4840|
|Contact: Brenda Eng 415-600-1775|
|United States, New York|
|Columbia University/ New York Presbyterian Hospital||Recruiting|
|New York, New York, United States, 10032|
|Contact: Abby Siegel, MD 212-305-9781|
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina||Recruiting|
|Charleston, South Carolina, United States, 29425|
|Contact: Andie R Adelman 843-792-1507|
|Contact: Melanie B Thomas, M.D. 843-792-5085|
|Principal Investigator: Melanie Thomas, MD|
|United States, Tennessee|
|Tennessee Oncology, PLLC at Sarah Cannon Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37203|
|Contact: Johanna Bendell, MD 615-329-7274|
|Principal Investigator:||Melanie B. Thomas, MD||Medical University of South Carolina|