Doxorubicin By Infusion or Chemoembolization in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
Liver Cancer
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring advanced adult primary liver cancer, adult primary hepatocellular carcinoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed hepatocellular carcinoma (HCC) Advanced, unresectable disease No clinically significant ascites No modified Child-Pugh class C liver disease No main portal vein occlusion/involvement No extrahepatic tumor of any kind PATIENT CHARACTERISTICS: Age 18 and over (16 and over for patients residing in Scotland) Performance status ECOG 0-2 Life expectancy More than 3 months Hematopoietic Absolute neutrophil count ≥ 1,500/mm^3 Hemoglobin ≥ 8.5 g/dL Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin < 5.0 mg/dL Transaminases < 2.5 times upper limit of normal (ULN) INR < 1.5 Renal Creatinine < 2 times ULN Cardiovascular No New York Heart Association class III or IV cardiac disease No acute angina No significant peripheral vascular disease No thrombosis of main portal vein LVEF ≥ 50% Other Not pregnant or nursing Fertile patients must use effective contraception No other concurrent serious medical condition No serious infection No psychological, familial, sociological, or geographical factors that would preclude study compliance No other malignancy within the past 5 years except carcinoma in situ of the cervix or non-melanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No prior biologic therapy for advanced unresectable HCC Chemotherapy No prior systemic or regional chemotherapy No prior chemotherapy for advanced unresectable HCC No other concurrent anticancer chemotherapy Endocrine therapy No prior hormonal therapy for advanced unresectable HCC Radiotherapy No prior radiotherapy for advanced unresectable HCC No other concurrent anticancer radiotherapy Surgery More than 7 days since prior major surgery More than 3 days since prior laparoscopy Other More than 4 weeks since prior investigational agents More than 6 weeks since prior ablative therapy and must have radiological evidence of progression if ablated site is the only site of disease No other concurrent investigational agents
Sites / Locations
- Cancer Research UK Clinical Trials Unit - Birmingham
- Bristol Haematology and Oncology Centre
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
- Royal Liverpool University Hospital
- Hammersmith Hospital
- Freeman Hospital
- Royal South Hants Hospital
- Royal Infirmary of Edinburgh at Little France
- Royal Infirmary Edinburgh
- West of Scotland Cancer Centre