chemoembolization in treating patients with primary liver cancer or metastases to the liver

Conditions: Liver Cancer; Metastatic Cancer

Summary: rationale: chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. purpose: phase ii trial to study the effectiveness of chemoembolization in treating patients who have primary liver cancer or metastases to the liver that cannot be surgically removed.

objectives: * evaluate time to progression of disease in patients with unresectable hepatocellular carcinoma or neuroendocrine hepatic metastases undergoing chemoembolization. * evaluate tumor response achievable with chemoembolization in this patient population. * evaluate the toxicities of this treatment in these patients. * evaluate survival of these patients following this treatment. * evaluate extrahepatic patterns of failure following chemoembolization, to determine whether intrahepatic progression may be forestalled and survival affected in these patients. * validate a consistent method of performing chemoembolization in a multicenter setting. outline: patients are stratified according to disease (hepatocellular carcinoma vs neuroendocrine hepatic metastases). patients undergo placement of a visceral arterial catheter. patients receive doxorubicin, mitomycin, and cisplatin as a chemoemulsion via the arterial catheter into 1 hepatic lobe only. immediately following delivery of the chemoemulsion, particulate embolization is performed. the opposite lobe, if involved, is treated within 3-5 weeks of treatment of the initial lobe. in the absence of unacceptable toxicity, each involved lobe is treated separately a second time, in the same sequence, beginning 8 weeks after the last lobular chemoembolization. after completion of all protocol therapy, retreatment on study of either lobe is allowed for regrowth, recurrence, or new disease, provided at least 3 months have elapsed since the initial treatment of that lobe. patients are followed for 5 years. projected accrual: a total of 19-42 patients will be accrued for this study within 1 year.

Eligibility criteria:
inclusion criteria: * biopsy-proven intrahepatic hepatocellular carcinoma or neuroendocrine tumor. * unresectable. * bidimensionally measurable disease by computed tomography (ct), magnetic resonance imaging (mri), or ultrasound scanning (us) within 6 weeks of registration. * evidence of patent portal vasculature by doppler us, mri, or angiography. * serum total bilirubin \< 2.0 mg/dl and serum creatinine \< 2.0 mg/dl within 4 weeks of registration. * absolute neutrophil count (anc) \> 2000/µl and platelets \> 50,000/µl within 4 weeks of registration. * expected survival of at least 3 months. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * age \>= 18 years. exclusion criteria: * evidence of extrahepatic disease that is likely to be life-threatening within 3 months, such as brain or symptomatic lung metastases. * previous intra-arterial or intra-hepatic chemotherapy or prior systemic chemotherapy within 4 weeks. * concurrent malignancy. * pregnant or breast-feeding women. * history of life-threatening contrast allergy.

Keywords: localized unresectable adult primary liver cancer advanced adult primary liver cancer recurrent adult primary liver cancer adult primary hepatocellular carcinoma liver metastases