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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00041275
First received: July 8, 2002
Last updated: September 19, 2013
Last verified: September 2002
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Double Blind Trial Of Megestrol Acetate Versus Placebo For The Treatment Of Inoperable Hepatocellular Carcinoma

Resource links provided by NLM:


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
Study Completion Date: August 2011
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Bangladesh
Bangabandhu Sheikh Mujib Medical University
Dhaka, Bangladesh, 1000
Indonesia
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
National Cancer Institute
Ha Noi, Vietnam
Cho Ray Hospital
Ho Chi Minh City, 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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00041275     History of Changes
Other Study ID Numbers: CDR0000069460, NMRC-AHCC02, EU-20203
Study First Received: July 8, 2002
Last Updated: September 19, 2013
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

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Liver Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Megestrol
Megestrol Acetate
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Appetite Stimulants
Central Nervous System Stimulants
Central Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014