Bevacizumab and Erlotinib or Sorafenib as First-Line Therapy in Treating Patients With Advanced Liver Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Medical University of South Carolina
Study ID
NCT00881751
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 116 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Apr 15, 2009
Start date
Mar 31, 2009
Status verified
Oct 2015
Primary completion
May 31, 2016
Completion
Feb 28, 2017

Study Design

Enrollment
95 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: bevacizumab and erlotinib
    Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28.
  • Active Comparator: Arm 2: sorafenib tosylate
    Patients receive oral sorafenib tosylate twice daily on days 1-28.

Primary Outcome Measure

Overall Survival [ Time Frame: from date of day 1 until the date of death ]

Locations (6)

FacilityCityStateZIPSite coordinators
USC/Norris Comprehensive Cancer Center and HospitalLos AngelesCalifornia90033-0804-
California Pacific Medical CenterSan FranciscoCalifornia94115-
Columbia University/ New York Presbyterian HospitalNew YorkNew York10032-
Hollings Cancer Center at Medical University of South CarolinaCharlestonSouth Carolina29425-
Tennessee Oncology, PLLCat Sarah Cannon Cancer CenterNashvilleTennessee37203-
UVA Cancer CenterCharlottesvilleVirginia22908-

Find similar trials in Los Angeles, CA

By condition
Liver cancer
By specialty
OncologyGI oncologyHepatology
By research site
USC/Norris Comprehensive Cancer Center and Hospital· Los Angeles, CACalifornia Pacific Medical Center· San Francisco, CAColumbia University/ New York Presbyterian Hospital· New York, NYHollings Cancer Center at Medical University of South Carolina· Charleston, SCTennessee Oncology, PLLCat Sarah Cannon Cancer Center· Nashville, TNUVA Cancer Center· Charlottesville, VA

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