Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NTR411; EMC 04-046
Study information
Scientific title
Acronym
HCC
Study hypothesis
Previous trials showed that both doxorubicin and thalidomide have anti-tumour activity against hepatocellular carcinoma (HCC). There are indications that these two agents interact synergistically and have non-overlapping toxicity profiles. This trial studies the feasibility and efficacy of doxorubicin combined with thalidomide for the treatment of hepatocellular carcinoma, compared with doxorubicin as single agent.
Ethics approval
Received from the local medical ethics committee
Study design
Randomised active controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Hepatocellular cancer
Intervention
Control arm: doxorubicin 60 mg/m^2 day 1, three weekly course with in total 6 cycles (maximum 360 mg/m2) given intravenously in 15 minutes.
Experimental arm: doxorubicin treatment as in control arm plus from day 3 on, thalidomide 200 mg daily administered in the evening. When doxorubicin administration has finished, thalidomide should be continued until progression of disease.
Intervention type
Drug
Phase
Not Specified
Drug names
Doxorubicin, thalidomide
Primary outcome measure
One-year survival
Secondary outcome measures
1. Response rate scored according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria
2. Time to progression
3. Quality of life
4. Toxicity
Overall trial start date
17/06/2004
Overall trial end date
01/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30
Participant 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
Recruitment start date
17/06/2004
Recruitment end date
01/01/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Erasmus MC - Daniel den Hoed
Rotterdam
3075 EA
Netherlands
Sponsor information
Organisation
Erasmus Medical Centre (Netherlands)
Sponsor details
Department of Medical Oncology
P.O. Box 5201
Rotterdam
3008 AE
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Not defined
Funder name
Not provided at time of registration
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list