No registrations found.
ID
Source
Brief title
Health condition
hepatocellular cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 1-year survival.
Secondary outcome
Response rate scored according to RECIST criteria, time to progression, quality of life, and toxicity.
Background summary
N/A
Study objective
Previous trials showed that both doxorubicin and thalidomide have anti-tumor 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.
Intervention
Control arm: doxorubicin 60 mg/m2 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 administerd in the evening. When doxorubicin administration has finished, thalidomide should be continued until progression of disease.
S. Sleijfer
Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 7034447
s.sleijfer@erasmusmc.nl
S. Sleijfer
Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 7034447
s.sleijfer@erasmusmc.nl
Inclusion criteria
Histologically proven HCC, irresectable tumor, failure to previous treatment, WHO 0-2, at least 4 weeks since prior treatment with HMG-Coa reductase inhibitors or systemic immunosuppresiva, adequate hepatic and bone marrow function.
Exclusion criteria
Prior treatment with doxorubicin or thalidomide, uncontrolled hypertension, unstable angina, arrhythmias requiring treatment, MI, thrombo-embolic events requiring treatment, congestive heartfailure or cardiomyopathy requiring treatment, peripheral neuropathy.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL371 |
| NTR-old | NTR411 |
| Other | : EMC 04-046 |
| ISRCTN | ISRCTN53872240 |