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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON21497

Enrollment

Registered

2005-09-20

Start date

2004-06-17

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hepatocellular cancer

Interventions

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 plu

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The 1-year survival.	—

Secondary

Measure	Time frame
Response rate scored according to RECIST criteria, time to progression, quality of life, and toxicity.	—

Contacts

Public ContactS. Sleijfer

Department of Oncology, Erasmus MC Cancer institute, room He 116

s.sleijfer@erasmusmc.nl+31 10 7034447

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)