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Status:

UNKNOWN

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

Lead Sponsor:

University Hospital Birmingham

Conditions:

Liver Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE3

Brief Summary

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. Chemoembolizat...

Detailed Description

OBJECTIVES: Primary * Compare the survival of patients with advanced unresectable primary hepatocellular carcinoma treated with intravenous doxorubicin hydrochloride vs doxorubicin hydrochloride che...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    April 1 2004

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    Estimated Enrollment :

    280 Patients enrolled

    Trial Details

    Trial ID

    NCT00079027

    Start Date

    April 1 2004

    Last Update

    December 18 2013

    Active Locations (10)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 3 (10 locations)

    1

    Cancer Research UK Clinical Trials Unit - Birmingham

    Birmingham, England, United Kingdom, B15 2TT

    2

    Bristol Haematology and Oncology Centre

    Bristol, England, United Kingdom, BS2 8HW

    3

    Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

    Cambridge, England, United Kingdom, CB2 2QQ

    4

    Royal Liverpool University Hospital

    Liverpool, England, United Kingdom, L69 3GA