drugset / Trial / NCT00867321

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

NCT00867321

RandomizedParallel-groupOpen-labelTreatment

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. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of liver cancer by blocking blood flow to the tumor. PURPOSE: This randomized phase I/II trial is studying the best dose of bevacizumab when given together with sorafenib as first-line therapy in treating patients with locally advanced or metastatic liver cancer.(Phase I closed to accrual as of 11/03/2010)

Timeline

Start
2009-04
Primary completion
2012-04
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Bevacizumab Monoclonal antibody 1.25 mg/kg Intravenous
Subject Bevacizumab Monoclonal antibody 2.5 mg/kg Intravenous
Subject Sorafenib Small molecule 200 mg Oral
Subject Sorafenib Small molecule 400 mg Oral

Indications