Heat Therapy in Treating Patients With Unresectable Primary or Metastatic Liver Cancer

OBJECTIVES: I. Determine the efficacy of radiofrequency ablation in patients with primary or
metastatic liver cancer. II. Determine disease free survival, local recurrence rate in
treated lesions as compared to known recurrence rates after hepatic cryoablation, and overall
survival in this patient population receiving this regimen.

OUTLINE: Patients undergo laparoscopic or open laparotomy surgical procedure to identify
unresectable tumors by ultrasound. Tumors are heated to a target temperature by electrodes
for a maximum of 20 minutes. To achieve a 1 cm margin of ablated tissue around each lesion,
multiple ablation courses may be performed, depending on the size of the lesions and the time
required to complete the treatment. Patients may be retreated if tumor recurs or new disease
appears. Patients are followed at 1 month, every 3 months for the first 2 years, every 6
months for next 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A maximum of 59 patients will be accrued for this study.

DISEASE CHARACTERISTICS: Diagnosis of unresectable malignant primary or metastatic liver
tumors Tumors are deemed unresectable based on the following factors: 1-10 liver tumors
Bilobar liver tumors Location of 1 or more lesions near a major intrahepatic vascular
structure (hepatic vein, portal vein, vena cava) Severe cirrhosis to preclude a major liver
resection No unresectable extrahepatic disease Prior failure of other therapeutic
modalities allowed No more than moderate ascites No hepatic encephalopathy

PATIENT CHARACTERISTICS: Age: Any age Performance status: Zubrod 0-1 Life expectancy: At
least 3 months Hematopoietic: Not specified Hepatic: No severe liver dysfunction (Child's
Class C) Bilirubin no greater than 3.0 mg/dL Albumin no greater than 3.0 mg/dL PT no
greater than 50% above normal Renal: No renal dysfunction Creatinine less than 2.0 mg/dL
Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception No altered mental status No active infection

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: At least 4 weeks
since prior chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks
since prior radiotherapy Surgery: See Disease Characteristics