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.

Condition	Treatment or Intervention	Phase
localized unresectable adult primary liver cancer advanced adult primary liver cancer adult primary hepatocellular carcinoma	Drug: megestrol  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: progestin therapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  20 Years and above,  Genders Eligible for Study:  Both

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

Bangladesh
      Bangabandhu Sheikh Mujib Medical University, Dhaka,  1000,  Bangladesh; Recruiting
Indonesia
      Rumah Sakit Sanglah, Bali,  Indonesia; Recruiting
Korea, Republic of
      St. Vincent Hospital, Suwon,  442-060,  Korea, Republic of; Recruiting
Myanmar
      Yangon General Hospital, Yangon,  Myanmar; Recruiting
New Zealand
      Auckland Hospital, Auckland,  5,  New Zealand; Recruiting
Philippines
      Davao Doctors Hospital, Davao City,  Philippines; Recruiting
Singapore
      Changi General Hospital, Singapore,  529889,  Singapore; Recruiting
      National Cancer Centre - Singapore, Singapore,  169608,  Singapore; Recruiting
Taiwan, Province of China
      Chang Gung Memorial Hospital, Taipei, Taipei,  333,  Taiwan, Province of China; Recruiting
Thailand
      Ramathibodi Hospital, Bangkok,  10400,  Thailand; Recruiting
Vietnam
      Cho Ray Hospital, Ho Chi Minh City,  Vietnam; Recruiting
      National Cancer Institute, Ha Noi,  Vietnam; Recruiting

Study chairs or principal investigators

Pierce Chow, MD, PhD,  Study Chair,  National Cancer Centre - Singapore   

Study ID Numbers:  CDR0000069460; NMRC-AHCC02; EU-20203; NCT00041275
Record last reviewed:  November 2002
Last Updated:  April 4, 2005
Record first received:  July 8, 2002
ClinicalTrials.gov Identifier:  NCT00041275
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08