Hepatic Arterial Chemoembolization With Cisplatin or Internal Radiation Therapy in Treating Patients With Advanced Liver Cancer That Cannot Be Removed By Surgery

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. In this case, chemotherapy is given through the artery (hepatic artery) that brings blood to the tumor. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. It is not yet known whether hepatic arterial chemoembolization with cisplatin is more effective than internal radiation therapy in treating liver cancer.

PURPOSE: This randomized phase III trial is studying hepatic arterial chemoembolization with cisplatin to see how well it works compared to internal radiation therapy in treating patients with advanced liver cancer that cannot be removed by surgery.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: National Cancer Institute (NCI)
• Treatments: Cisplatin

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