Megestrol in Treating Patients With Liver Cancer That Cannot Be Removed By Surgery - Full Text View

Sponsored by:	National Medical Research Council (NMRC), Singapore
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00041275

Purpose

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	Intervention	Phase
Liver Cancer	Drug: megestrol acetate	Phase III

MedlinePlus related topics: Cancer Liver Cancer

Drug Information available for: Megestrol acetate Megestrol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control
Official Title:	Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Survival measured weekly [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life as measured by EORTC quality of life instrument monthly [ Designated as safety issue: No ]

Estimated Enrollment:	300
Study Start Date:	May 2002
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00041275

Locations

Bangladesh
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh, 1000
Indonesia, Bali
Rumah Sakit Sanglah
Denpasar, Bali, Indonesia, 20114
Korea, Republic of
St. Vincent Hospital
Suwon, Korea, Republic of, 442-060
Myanmar
Yangon General Hospital
Yangon, Myanmar
New Zealand
Auckland City Hospital
Auckland, New Zealand, 5
Philippines
Davao Doctors Hospital
Davao City, Philippines
Singapore
Changi General Hospital
Singapore, Singapore, 529889
National Cancer Centre - Singapore
Singapore, Singapore, 169608
Taiwan
Chang-Gung Memorial Hospital - Taipei
Taipei, Taiwan, 333
Thailand
Ramathibodi Hospital
Bangkok, Thailand, 10400
Vietnam
Cho Ray Hospital
Ho Chi Minh City, Vietnam
National Cancer Institute
Ha Noi, Vietnam

Sponsors and Collaborators

National Medical Research Council (NMRC), Singapore

Investigators

Study Chair:

Pierce Chow, MD, PhD, MBBS, FRCS, FAMS

National Cancer Centre, Singapore

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000069460, NMRC-AHCC02, EU-20203
Study First Received:	July 8, 2002
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00041275
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

localized unresectable adult primary liver cancer
advanced adult primary liver cancer
adult primary hepatocellular carcinoma

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Megestrol
Carcinoma
Liver Neoplasms

Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Megestrol Acetate
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Antineoplastic Agents, Hormonal
Contraceptive Agents
Antineoplastic Agents
Physiological Effects of Drugs
Contraceptives, Oral
Contraceptive Agents, Female
Central Nervous System Stimulants

Reproductive Control Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Contraceptives, Oral, Synthetic
Central Nervous System Agents
Appetite Stimulants

ClinicalTrials.gov processed this record on January 16, 2009