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

Original Study ID : CDR0000069460

Secondary ID : Array

NCT ID : NCT00041275

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

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

Brief 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.

Source : National Cancer Institute (NCI)

Detailed 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.

Overall Status : Active, not recruiting

Start Date : May 2002

Official Title : Phase 3

Phase : Interventional

Study Design : Treatment, Randomized, Double-Blind, Placebo Control

Enrollment : 300

Verification Date : September 2002

First Received Date : July 8, 2002

Trial Eligibility

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

Gender : Both

Minimum Age : 20 Years

Maximum Age : N/A

Healthy Volunteers : No

Facilities

Facility Name : Bangabandhu Sheikh Mujib Medical University

City : Dhaka

Zip Code : 1000

Country : Bangladesh

Facility Name : Rumah Sakit Sanglah

City : Denpasar

State : Bali

Zip Code : 20114

Country : Indonesia

Facility Name : St. Vincent Hospital

City : Suwon

State : Bali

Zip Code : 442-060

Country : Korea, Republic of

Facility Name : Yangon General Hospital

City : Yangon

State : Bali

Zip Code : 442-060

Country : Myanmar

Facility Name : Auckland City Hospital

City : Auckland

State : Bali

Zip Code : 5

Country : New Zealand

Facility Name : Davao Doctors Hospital

City : Davao City

State : Bali

Zip Code : 5

Country : Philippines

Facility Name : Changi General Hospital

City : Singapore

State : Bali

Zip Code : 529889

Country : Singapore

Facility Name : National Cancer Centre - Singapore

City : Singapore

State : Bali

Zip Code : 169608

Country : Singapore

Facility Name : Chang-Gung Memorial Hospital - Taipei

City : Taipei

State : Bali

Zip Code : 333

Country : Taiwan

Facility Name : Ramathibodi Hospital

City : Bangkok

State : Bali

Zip Code : 10400

Country : Thailand

Facility Name : Cho Ray Hospital

City : Ho Chi Minh City

State : Bali

Zip Code : 10400

Country : Vietnam

Facility Name : National Cancer Institute

City : Ha Noi

State : Bali

Zip Code : 10400

Country : Vietnam

Clinical Trial Name -Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery