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

NCT00079027 | Unknown Phase 3

• 4 other identifiers: CDR0000353298CRUK-HEP-1EU-20340ISRCTN78345798
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 10

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. 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.

Conditions

Liver Cancer

Keywords

advanced adult primary liver cancer; adult primary hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (6)

• 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

• Toxicity

• Health economics

Interventions

doxorubicin hydrochloride DRUG

hepatic artery embolization PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University Hospital Birmingham: lead

Study Sites (10)

Cancer Research UK Clinical Trials Unit - Birmingham

Birmingham, England, B15 2TT, United Kingdom

Location

Bristol Haematology and Oncology Centre

Bristol, England, BS2 8HW, United Kingdom

Location

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust

Cambridge, England, CB2 2QQ, United Kingdom

Location

Royal Liverpool University Hospital

Liverpool, England, L69 3GA, United Kingdom

Location

Hammersmith Hospital

London, England, W12 OHS, United Kingdom

Location

Freeman Hospital

Newcastle upon Tyne, England, NE7 7DN, United Kingdom

Location

Royal South Hants Hospital

Southampton, England, SO14 0YG, United Kingdom

Location

Royal Infirmary of Edinburgh at Little France

Edinburgh, Scotland, EH16 4SA, United Kingdom

Location

Royal Infirmary Edinburgh

Edinburgh, Scotland, EH3 9YW, United Kingdom

Location

West of Scotland Cancer Centre

Glasgow, Scotland, G11 6NT, United Kingdom

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Doxorubicin

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• O. J. Garden

  Royal Infirmary of Edinburgh at Little France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 8, 2004
• First Posted: March 9, 2004
• Study Start: April 1, 2004
• Last Updated: December 18, 2013

Record last verified: 2007-05

Locations

GB (10)