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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00041275
• Other study ID #: CDR0000069460
• Secondary ID: NMRC-AHCC02EU-20
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2002
• Last updated: September 19, 2013
• Start date: May 2002
• Est. completion date: August 2011

Study information

• Verified date: September 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: August 2011
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Liver Cancer
• Liver Neoplasms

Intervention

Drug:
• megestrol acetate

Locations

Country	Name	City	State
Bangladesh	Bangabandhu Sheikh Mujib Medical University	Dhaka
Indonesia	Rumah Sakit Sanglah	Denpasar	Bali
Korea, Republic of	St. Vincent Hospital	Suwon
Myanmar	Yangon General Hospital	Yangon
New Zealand	Auckland City Hospital	Auckland
Philippines	Davao Doctors Hospital	Davao City
Singapore	Changi General Hospital	Singapore
Singapore	National Cancer Centre - Singapore	Singapore
Taiwan	Chang-Gung Memorial Hospital - Taipei	Taipei
Thailand	Ramathibodi Hospital	Bangkok
Vietnam	National Cancer Institute	Ha Noi
Vietnam	Cho Ray Hospital	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
National Medical Research Council (NMRC), Singapore

Countries where clinical trial is conducted

Bangladesh,  Indonesia,  Korea, Republic of,  Myanmar,  New Zealand,  Philippines,  Singapore,  Taiwan,  Thailand,  Vietnam, 

References & Publications (1)

Chow PK, Machin D, Chen Y, Zhang X, Win KM, Hoang HH, Nguyen BD, Jin MY, Lobo R, Findlay M, Lim CH, Tan SB, Gandhi M, Soo KC; Asia-Pacific Hepatocellular Carcinoma Trials Group. Randomised double-blind trial of megestrol acetate vs placebo in treatment-na — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival measured weekly			No
Secondary	Quality of life as measured by EORTC quality of life instrument monthly			No