RATIONALE: Estrogen can stimulate the growth of cancer cells. Hormone therapy using tamoxifen may fight liver cancer by blocking the absorption of estrogen. It is not yet known whether receiving tamoxifen is more effective than no further therapy in treating patients with primary liver cancer.

PURPOSE: Randomized phase III trial to compare high-dose tamoxifen with no further treatment in treating patients with liver cancer that cannot be surgically removed.

Condition	Treatment or Intervention	Phase
advanced adult primary liver cancer adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer Quality of Life	Drug: tamoxifen	Phase III

Further Study Details: 

OBJECTIVES: I. Assess the therapeutic role of tamoxifen in patients with inoperable hepatocellular carcinoma in terms of overall survival and quality of life.

PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled study of tamoxifen.

Patients are randomized to one of 3 treatment arms.

Arm I: Patients receive placebo orally twice daily for one year.

Arms II and III: Patients receive tamoxifen, at 1 of 2 different doses, orally twice daily for one year.

Quality of life is assessed before treatment and then monthly thereafter.

Patients are followed monthly until death.

PROJECTED ACCRUAL: This study will accrue 300 patients.

Ages Eligible for Study:  10 Years   -   90 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically or radiologically confirmed inoperable hepatocellular carcinoma
• Serum alfa-feto protein level at least 500 ug/L OR Positive lipiodol uptake

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemoembolization therapy for disease; No prior systemic chemotherapy for disease
• Endocrine therapy: Not specified
• Radiotherapy: Not specified
• Surgery: No prior surgery for disease
• Other: No prior percutaneous injection

--Patient Characteristics--

• Age: 10 to 90
• Performance status: ECOG 0-3
• Life expectancy: Not specified
• Hematopoietic: Not specified
• Hepatic: Not specified
• Renal: Creatinine less than 1.7 mg/dL
• Other: No encephalopathy

Hong Kong
      Prince of Wales Hospital, Shatin, New Territories,  Hong Kong
Indonesia, Bali
      University of Udayana, Sanglah, Denpasar,  Bali,  Indonesia
Malaysia
      Universiti Kebangsaan Malaysia, Bangi,  43600,  Malaysia
New Zealand
      Wellington Cancer Centre, Wellington,  6039,  New Zealand
Pakistan
      National Cancer Institute - Karachi, Karachi,  Pakistan
      Nishtar Medical College, Multan, Multan,  Pakistan
Singapore
      National Cancer Centre - Singapore, Singapore,  169608,  Singapore
      Tan Tock Seng Hospital, Singapore,  1130,  Singapore

Study chairs or principal investigators

Pierce Chow,  Study Chair,  National Cancer Centre - Singapore   

Study ID Numbers:  CDR0000066444; NMRC-AHCC01; EU-98018
Record last reviewed:  August 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003424
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08