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

National Medical Research Council (NMRC), Singapore300 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

300

Conditions

Liver Cancer

Interventions

megestrol acetateDRUG

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (12)

Bangabandhu Sheikh Mujib Medical University

Dhaka, Bangladesh

Yangon General Hospital

Yangon, Burma

Rumah Sakit Sanglah

Denpasar, Bali, Indonesia

Outcomes

Primary Outcomes

Survival measured weekly

Secondary Outcomes

Quality of life as measured by EORTC quality of life instrument monthly

Data from ClinicalTrials.gov

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