Internal Radiation Therapy in Treating Patients With Primary Liver Cancer That Cannot Be Removed by Surgery

Clinical Trial of Sir Spheres® in Patients With Primary Hepatocellular Carcinoma

RATIONALE: Specialized internal radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This clinical trial is studying how well internal radiation therapy works in treating patients with primary liver cancer that cannot be removed by surgery.

OBJECTIVES:

Primary

• Determine tumor response to selective internal radiation therapy comprising yttrium Y 90 resin microspheres (Sir-Spheres®) in patients with unresectable primary hepatocellular carcinoma.

Secondary

• Determine the toxicity of this regimen in these patients.
• Determine the health-related quality of life of patients receiving this regimen.
• Determine the survival of patients receiving this regimen.

OUTLINE: Patients undergo selective internal radiation therapy comprising yttrium Y 90 resin microspheres (Sir-Spheres®) via catheter directly into the hepatic artery on day 1.

Health-related quality of life is assessed prior to initial treatment and then periodically thereafter.

After completion of study treatment, patients are followed periodically for 12-24 months.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Inclusion Criteria:

• Diagnosis of hepatocellular carcinoma

  • Not amenable to surgical resection or immediate liver transplantation

    • Destaging of tumor prior to surgical resection or transplantation allowed

• Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest diameter to be recorded) ≥ 10 mm by contrasted CT scan

  • No equivocal, nonmeasurable, or nonevaluable liver cancer

• No more than 75% replacement of normal liver by tumor

• Cancer of the Liver Italian Program (CLIP) stage 1-3 disease

• No extra-hepatic metastases as determined by CT scan or MRI

Exclusion Criteria:

• Life expectancy ≥ 3 months
• Karnofsky performance status 50-100%
• Creatinine ≤ 1.5 mg/dL
• Bilirubin ≤ 2.0 mg/dL
• Albumin ≥ 3 g/dL
• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 65,000/mm³
• INR ≤ 1.4
• Hemoglobin > 9 g/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• No nonmalignant disease that would render the patient ineligible for treatment according to this protocol
• No hepatic arterial anatomy that would prevent the administration of study drug into the liver
• Less than 20% arteriovenous lung shunting on a technetium 99m-labeled macroaggregated albumin nuclear scan
• No other malignancy within the past 5 years except for cured basal cell carcinoma of the skin or cured carcinoma in situ of the uterine cervix

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• More than 90 days since prior surgery, chemotherapy, or locally ablative technique for the liver cancer
• More than 4 weeks since prior and no other concurrent investigational drug or agent/procedure (i.e., participation in another trial)
• No prior radiotherapy to the upper abdomen that included the liver in the treatment field
• No capecitabine within 8 weeks before or after study treatment
• No other anticancer treatment (except surgical resection) for liver cancer during and for 3 months after completion of study treatment