Hepatocellular Carcinoma Clinical Trial
Official title:
Gemcitabine and Cisplatin With Erlotinib in Hepatocellular Carcinoma (HCC) and Biliary Tree Cancer (BTC) (Intra- and Extra-hepatic Cholangiocarcinoma, Bile Duct Cancer, Adenocarcinoma of the Ampulla of Vater and Gallbladder Carcinoma)
This is a single arm phase II trial of Gemcitabine and Oxaliplatin (Gem-Ox) with Erlotinib (Tarceva) for the treatment of hepatocellular carcinoma (HCC) and biliary tree cancer (BTC) patients with platelet counts 100,000/µL. The purpose of this study is to determine the tumor control rate following treatment with GEM-OX combined with Tarceva in patients with HCC. Tumor control rate is defined as the percentage of patients achieving a complete response, partial response, or stable disease at 24 weeks following treatment.
The incidence and mortality of HCC has increased in the United States. Promising responses have been observed in HCC patients treated with gemcitabine and cisplatin, inclusing good disease stabilization and progression free survival. Cisplatin-gemcitabine enhances the cytotoxicity of cisplatin by increasing the formation of cytotoxic platinum DNA adducts. Similarly, Oxaliplatin also has DNA cross linkage properties and one could assume that its combination with gemcitabine is likely to potentiate the cytotoxicity of the latter. Erlotinib has also been reported to result in clinical benefit in HCC and BTC patients. Based on these prior findings, we embarked on this phase II protocol of gemcitabine, oxaliplatin, and erlotinib in HCC and BTC patients. ;
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