A randomised phase II study of doxorubicin combined with thalidomide versus doxorubicin alone for patients with unresectable hepatocellular carcinoma
| ISRCTN | ISRCTN53872240 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53872240 |
| Protocol serial number | NTR411; EMC 04-046 |
| Sponsor | Erasmus Medical Centre (Netherlands) |
| Funder | Not provided at time of registration |
- Submission date
- 27/01/2006
- Registration date
- 27/01/2006
- Last edited
- 03/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr S. Sleijfer
Scientific
Scientific
Erasmus MC - Daniel den Hoed
Department of Medical Oncology
Groene Hilledijk 301
Rotterdam
3075 EA
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised active controlled parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | HCC |
| Study objectives | 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(s) | Received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Doxorubicin, thalidomide |
| Primary outcome measure(s) |
One-year survival |
| Key secondary outcome measure(s) |
1. Response rate scored according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria |
| Completion date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 17/06/2004 |
| Date of final enrolment | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Erasmus MC - Daniel den Hoed
Rotterdam
3075 EA
Netherlands
3075 EA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
