Nexavar is FDA approved for hepatocellular carcinoma as a single agent. Tarceva is a targeted anticancer drug that works by blocking a biological pathway referred to as the epidermal growth factor receptor (EGFR) pathway. The EGFR pathway is involved in cell growth and replication and when mutated or altered, excessive replication of cells can occur. Tarceva has been shown to improve treatment outcomes in selected patients with advanced non–small cell lung cancer or pancreatic cancer, and is also being evaluated in the treatment of other types of cancer. A recent phase II study suggested that it is effective with Nexavar for liver cancer. Tarceva alone is still in trials. Several have been completed and not reported; one is ongoing: Erlotinib in Treating Patients With Unresectable Liver, Bile Duct, or Gallbladder Cancer, NCT00033462.
There are in total two phase II trials that support Tarceva.
However, for the combination there is only one trial and two more are ongoing: Efficacy and Safety Study of Bevacizumab and Erlotinib to Treat Primary Liver Cancer That Cannot be Removed By Surgery NCT00242502 and Bevacizumab and Erlotinib in Treating Patients With Advanced Liver Cancer NCT00365391(competed but not published). Some of the caveats to introuducing this regimen inot the clcinal mainstream can be found at: http://www.hemonctoday.com/article.aspx?rid=36645
Philip P, Mahoney M, Allmer C, et al. Phase II Study of Erlotinib (OSI-774) in Patients With Advanced Hepatocellular Cancer. Journal of Clinical Oncology. 2005; 23: 6657-6663.
Thomas MB, Morris JS, Chadha R et al. Phase II trial of the combination of bevacizumab and erlotinib in patients who have advanced hepatocellular carcinoma. Journal of Clinical Oncology [early online publication]. January 12, 2009.
Philip P, Mahoney M, Allmer C, et al. Phase II Study of Erlotinib (OSI-774) in Patients With Advanced Hepatocellular Cancer. Journal of Clinical Oncology. 2005; 23: 6657-6663.
Thomas MB, Morris JS, Chadha R et al. Phase II trial of the combination of bevacizumab and erlotinib in patients who have advanced hepatocellular carcinoma. Journal of Clinical Oncology [early online publication]. January 12, 2009.
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