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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma

Conditions
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Liver Cancer

Intervention / Treatment
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* Drug: megestrol acetate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: megestrol acetate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival measured weekly |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life as measured by EORTC quality of life instrument monthly |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized unresectable adult primary liver cancer, advanced adult primary liver cancer, adult primary hepatocellular carcinoma