UCSF Helen Diller Family Comprehensive Cancer Center
Protocol Summary

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Protocol No.CALGB-80802Principal InvestigatorVenook, Alan
PhaseIII (Cancer Control)
Age GroupAdultScopeNational
TitleSorafenib with or without Doxorubicin in Advanced Liver Cancer
Objective--To compare overall survival (OS) of patients treated with sorafenib and doxorubicin to that of those treated with sorafenib
Key Eligibility* Pathologically or cytologically proven hepatocellular carcinoma (HCC) - No known mixed histology or fibrolamellar variant * Locally advanced or metastatic disease - Patients with locally advanced disease must have disease deemed to be unresectable OR not be eligible for transplantation * Measurable disease, defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >/= 2 cm with conventional techniques or as >/= 1 cm with spiral CT scan * Child-Pugh score A * No known CNS tumors, including brain metastases
Applicable Disease SitesLiver
Therapies InvolvedChemotherapy multiple agents systemic
Chemotherapy non-cytotoxic
Chemotherapy single agent systemic
Drugs InvolvedAdriamycin (Doxorubicin)
Doxorubicin
Doxorubicin HCl (Doxorubicin)
Doxorubicin hydrochloride (Doxorubicin)
Lipodox (Doxorubicin)
Nexavar (Sorafenib)
Rubex (Doxorubicin)
Sorafenib
StatusOpen
Participating InstitutionsUniversity of California San Francisco : Jennifer Luan
Eligibility DocumentCALGB-80802_CTGov_Eligibility_NCT01015833.doc
ContactJennifer Luan Phone:415-514-6220
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Email:jennifer.luan@ucsf.edu