Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery

OBJECTIVES:

• Compare the overall survival of patients with inoperable hepatocellular carcinoma treated with megestrol vs placebo.
• Compare the quality of life of patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 2 treatment arms.

• Arm I: Patients receive oral megestrol twice daily for 1 year.
• Arm II: Patients receive an oral placebo twice daily for 1 year. Quality of life is assessed at baseline and then monthly for 1 year.

PROJECTED ACCRUAL: A minimum of 300 patients (200 for arm I and 100 for arm II) will be accrued for this study.

DISEASE CHARACTERISTICS:

• Diagnosis of hepatocellular carcinoma (HCC)

• Histologically confirmed OR
• Meets 2 of the following criteria:

• Radiological evidence of HCC on CT scan, MRI, or ultrasound
• Serum alpha-fetoprotein level at least 400 µg/L
• Positive lipiodol retention
• Not amenable to surgery

PATIENT CHARACTERISTICS:

Age:

• 20 to 100

Performance status:

• ECOG 0-3

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Bilirubin no greater than 5.8 mg/dL

Renal:

• Creatinine less than 1.7 mg/dL

Other:

• Not pregnant
• No clinical encephalopathy
• No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemoembolization for HCC
• No prior systemic chemotherapy for HCC

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics
• No prior surgery for HCC

Other:

• No prior percutaneous injection for HCC