- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00079027
Doxorubicin By Infusion or Chemoembolization in Treating Patients With Advanced Unresectable Hepatocellular Carcinoma (Liver Cancer)
A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, Advanced Hepatocellular Carcinoma
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
England
-
Birmingham, England, United Kingdom, B15 2TT
- Cancer Research UK Clinical Trials Unit - Birmingham
-
Bristol, England, United Kingdom, BS2 8HW
- Bristol Haematology and Oncology centre
-
Cambridge, England, United Kingdom, CB2 2QQ
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
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Liverpool, England, United Kingdom, L69 3GA
- Royal Liverpool University Hospital
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London, England, United Kingdom, W12 OHS
- Hammersmith Hospital
-
Newcastle-Upon-Tyne, England, United Kingdom, NE7 7DN
- Freeman Hospital
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Southampton, England, United Kingdom, SO14 0YG
- Royal South Hants Hospital
-
-
Scotland
-
Edinburgh, Scotland, United Kingdom, EH16 4SA
- Royal Infirmary of Edinburgh at Little France
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Edinburgh, Scotland, United Kingdom, EH3 9YW
- Royal Infirmary Edinburgh
-
Glasgow, Scotland, United Kingdom, G11 6NT
- West of Scotland Cancer Centre
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Overall survival
|
Secondary Outcome Measures
Outcome Measure |
---|
Toxicity
|
Overall response
|
Quality of life as assessed by EORTC QOL QLQ-30 and EORTC QLQ HCC18 at baseline and 10 and 24 weeks
|
Time to progression as assessed by RECIST criteria
|
Health economics
|
Proteomic and immunological analysis
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: O. J. Garden, Royal Infirmary of Edinburgh at Little France
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Digestive System Neoplasms
- Liver Diseases
- Carcinoma
- Carcinoma, Hepatocellular
- Liver Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Doxorubicin
- Liposomal doxorubicin
Other Study ID Numbers
- CDR0000353298
- CRUK-HEP-1
- EU-20340
- ISRCTN78345798
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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