Doxorubicin By Infusion or Chemoembolization in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00079027
First received: March 8, 2004
Last updated: December 17, 2013
Last verified: May 2007
  Purpose

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping the cells from dividing. Chemoembolization kills tumor cells by blocking the blood flow to the tumor and keeping chemotherapy drugs near the tumor. It is not yet known whether doxorubicin is more effective with or without chemoembolization in treating unresectable hepatocellular carcinoma (liver cancer).

PURPOSE: This randomized phase III trial is studying doxorubicin given by infusion to see how well it works compared to doxorubicin given by chemoembolization in treating patients with advanced liver cancer than cannot be removed by surgery.


Condition Intervention Phase
Liver Cancer
Drug: doxorubicin hydrochloride
Procedure: hepatic artery embolization
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, Advanced Hepatocellular Carcinoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall response [ Designated as safety issue: No ]
  • Quality of life as assessed by EORTC QOL QLQ-30 and EORTC QLQ HCC18 at baseline and 10 and 24 weeks [ Designated as safety issue: No ]
  • Time to progression as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Health economics [ Designated as safety issue: No ]
  • Proteomic and immunological analysis [ Designated as safety issue: No ]

Estimated Enrollment: 280
Study Start Date: April 2004
Detailed Description:

OBJECTIVES:

Primary

  • Compare the survival of patients with advanced unresectable primary hepatocellular carcinoma treated with intravenous doxorubicin hydrochloride vs doxorubicin hydrochloride chemoembolization.

Secondary

  • Compare the response rate in patients treated with these regimens.
  • Compare time to progression in patients treated with these regimens.
  • Compare the toxicity of these regimens in these patients.
  • Compare the quality of life of patients treated with these regimens.
  • Compare the health economic implications of these regimens in these patients.

OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to participating center, stage of disease, and alpha-fetoprotein levels (< 500 ng/mL vs ≥ 500 ng/mL). Patients are randomized to 1 of 2 treatment arms.

  • Arm I (control arm): Patients receive doxorubicin hydrochloride IV over 3-5 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
  • Arm II (chemoembolization arm): Patients undergo transarterial chemoembolization using DC Bead and doxorubicin hydrochloride. Chemoembolization repeats every 8 weeks for a total of 3 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and at weeks 10 and 24.

Patients are followed at 4 weeks and then every 12 weeks thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed hepatocellular carcinoma (HCC)

    • Advanced, unresectable disease
  • No clinically significant ascites
  • No modified Child-Pugh class C liver disease
  • No main portal vein occlusion/involvement
  • No extrahepatic tumor of any kind

PATIENT CHARACTERISTICS:

Age

  • 18 and over (16 and over for patients residing in Scotland)

Performance status

  • ECOG 0-2

Life expectancy

  • More than 3 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Hemoglobin ≥ 8.5 g/dL
  • Platelet count ≥ 100,000/mm^3

Hepatic

  • Bilirubin < 5.0 mg/dL
  • Transaminases < 2.5 times upper limit of normal (ULN)
  • INR < 1.5

Renal

  • Creatinine < 2 times ULN

Cardiovascular

  • No New York Heart Association class III or IV cardiac disease
  • No acute angina
  • No significant peripheral vascular disease
  • No thrombosis of main portal vein
  • LVEF ≥ 50%

Other

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No other concurrent serious medical condition
  • No serious infection
  • No psychological, familial, sociological, or geographical factors that would preclude study compliance
  • No other malignancy within the past 5 years except carcinoma in situ of the cervix or non-melanoma skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • No prior biologic therapy for advanced unresectable HCC

Chemotherapy

  • No prior systemic or regional chemotherapy
  • No prior chemotherapy for advanced unresectable HCC
  • No other concurrent anticancer chemotherapy

Endocrine therapy

  • No prior hormonal therapy for advanced unresectable HCC

Radiotherapy

  • No prior radiotherapy for advanced unresectable HCC
  • No other concurrent anticancer radiotherapy

Surgery

  • More than 7 days since prior major surgery
  • More than 3 days since prior laparoscopy

Other

  • More than 4 weeks since prior investigational agents
  • More than 6 weeks since prior ablative therapy and must have radiological evidence of progression if ablated site is the only site of disease
  • No other concurrent investigational agents
  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: NCT00079027

Locations
United Kingdom
Cancer Research UK Clinical Trials Unit - Birmingham
Birmingham, England, United Kingdom, B15 2TT
Bristol Haematology and Oncology Centre
Bristol, England, United Kingdom, BS2 8HW
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
Cambridge, England, United Kingdom, CB2 2QQ
Royal Liverpool University Hospital
Liverpool, England, United Kingdom, L69 3GA
Hammersmith Hospital
London, England, United Kingdom, W12 OHS
Freeman Hospital
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
Royal South Hants Hospital
Southampton, England, United Kingdom, SO14 0YG
Royal Infirmary Edinburgh
Edinburgh, Scotland, United Kingdom, EH3 9YW
Royal Infirmary of Edinburgh at Little France
Edinburgh, Scotland, United Kingdom, EH16 4SA
West of Scotland Cancer Centre
Glasgow, Scotland, United Kingdom, G11 6NT
Sponsors and Collaborators
University Hospital Birmingham
Investigators
Study Chair: O. J. Garden Royal Infirmary of Edinburgh at Little France
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00079027     History of Changes
Other Study ID Numbers: CDR0000353298, CRUK-HEP-1, EU-20340, ISRCTN78345798
Study First Received: March 8, 2004
Last Updated: December 17, 2013
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
advanced adult primary liver cancer
adult primary hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Doxorubicin
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014