Hepatic Arterial Chemoembolization With Cisplatin or Internal Radiation Therapy in Treating Patients With Advanced Liver Cancer That Cannot Be Removed By Surgery
Liver Cancer
About this trial
This is an interventional treatment trial for Liver Cancer focused on measuring adult primary hepatocellular carcinoma, advanced adult primary liver cancer, localized unresectable adult primary liver cancer, recurrent adult primary liver cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Diagnosis of 1 of the following: Histologically or cytologically confirmed hepatocellular carcinoma (HCC) Confined to the liver Vascular liver mass in the presence of cirrhosis Alpha-fetoprotein level > 500 ng/mL Measurable disease At least 1 unidimensionally measurable lesion > 20 mm by spiral CT scan Unresectable disease, due to tumor size or extent or presence of cirrhosis No metastatic disease, including brain metastases Locoregional lymph node metastases allowed No evidence of potential delivery of > 16.5 miCi (30 Gy absorbed dose) of radiotherapy to the lungs either during the first administration of yttrium Y 90 glass microspheres (TheraSphere®) or on cumulative delivery of radiation to the lungs over multiple treatments* No evidence of detectable technetium Tc 99m macroaggregated albumin (Tc-99m MAA) flow to the stomach or duodenum after application of established angiographic techniques to stop the flow* NOTE: *For patients randomized to the TheraSphere® arm only PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy More than 12 weeks Hematopoietic WBC > 2,500/mm^3 Absolute neutrophil count > 1,500/mm^3 Platelet count > 60,000/mm^3 No bleeding diathesis not correctable by usual forms of therapy Hepatic See Disease Characteristics Bilirubin < 2.0 mg/dL AST and/or ALT ≤ 5 times upper limit of normal Hepatitis allowed No portal hypertension with hepatofugal flow Renal Creatinine < 2.5 mg/dL Cardiovascular No symptomatic congestive heart failure No severe peripheral vascular disease that would preclude catheterization Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective double barrier or hormonal contraception during and for at least 30 days after completion of study treatment No ongoing or active infection No other uncontrolled illness No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No more than 1 prior systemic chemotherapy for HCC More than 4 weeks since prior IV chemotherapy and recovered More than 1 year since prior hepatic arterial cisplatin More than 4 months since other prior hepatic arterial chemotherapy Endocrine therapy Not specified Radiotherapy No prior external hepatic radiotherapy for HCC Surgery Not specified Other No other concurrent therapy for HCC No other concurrent investigational agents
Sites / Locations
- Hillman Cancer Center at University of Pittsburgh Cancer Institute