A randomised phase II study of doxorubicin combined with thalidomide versus doxorubicin alone for patients with unresectable hepatocellular carcinoma

Completed

• Conditions: Hepatocellular cancer; Malignant neoplasm of liver and intrahepatic bile ducts; Cancer

• Registration Number: ISRCTN53872240
• Lead Sponsor: Erasmus Medical Centre (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-01-27
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1. Histologically proven HCC
2. Irresectable tumour
3. Failure to previous treatment
4. World Health Organization (WHO) performance status 0 - 2
5. At least 4 weeks since prior treatment with HMG-Coa reductase inhibitors or systemic immunosuppresiva
6. Adequate hepatic and bone marrow function

Exclusion Criteria

1. Prior treatment with doxorubicin or thalidomide
2. Uncontrolled hypertension
3. Unstable angina
4. Arrhythmias requiring treatment
5. Myocardial infarction (MI)
6. Thrombo-embolic events requiring treatment
7. Congestive heart failure or cardiomyopathy requiring treatment
8. Peripheral neuropathy

Study & Design

• Study Type: Interventional
• Study Design: Not specified