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

National Medical Research Council (NMRC), Singapore

Status and phase: Completed; Phase 3

Conditions: Liver Cancer

Treatments: Drug: megestrol acetate

Study type: Interventional

Funder types: Other

Identifiers

NCT00041275

EU-20203

NMRC-AHCC02

CDR0000069460

Details and patient eligibility

About

RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using megestrol may fight liver cancer by blocking the uptake of estrogen. It is not yet known if megestrol is an effective treatment for liver cancer.

PURPOSE: Randomized phase III trial to determine the effectiveness of megestrol in treating patients who have liver cancer that cannot be removed by surgery.

Full description

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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