Overview

This trial is active, not recruiting.

Condition liver cancer
Treatments doxorubicin hydrochloride, hepatic artery embolization
Phase phase 3
Sponsor University Hospital Birmingham
Start date April 2004
Trial size 280 participants
Trial identifier NCT00079027, CDR0000353298, CRUK-HEP-1, EU-20340, ISRCTN78345798

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Primary purpose treatment

Primary Outcomes

Measure
Overall survival
time frame:

Secondary Outcomes

Measure
Overall response
time frame:
Quality of life as assessed by EORTC QOL QLQ-30 and EORTC QLQ HCC18 at baseline and 10 and 24 weeks
time frame:
Time to progression as assessed by RECIST criteria
time frame:
Toxicity
time frame:
Health economics
time frame:
Proteomic and immunological analysis
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Randomized Clinical Trial Evaluating the Benefits of Doxorubicin Chemoembolization Versus Systemic Doxorubicin in Patients With Unresectable, Advanced Hepatocellular Carcinoma
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).