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…
Bron
Verkorte titel
Aandoening
hepatocellular cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Geen registraties gevonden.
Uitkomstmaten
Primaire uitkomstmaten
The 1-year survival.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
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.
Onderzoeksproduct en/of interventie
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.
Publiek
S. Sleijfer
Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 7034447
s.sleijfer@erasmusmc.nl
Wetenschappelijk
S. Sleijfer
Gravendijkwal 230
Rotterdam 3015 CE
The Netherlands
+31 10 7034447
s.sleijfer@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL371 |
NTR-old | NTR411 |
Ander register | : EMC 04-046 |
ISRCTN | ISRCTN53872240 |