Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC)
|ClinicalTrials.gov Identifier: NCT00351195|
Recruitment Status : Terminated (Did not meet the criteria for continuation to second stage)
First Posted : July 12, 2006
Last Update Posted : August 26, 2008
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Drug: Etoposide Drug: Oxaliplatin Drug: Capecitabine||Phase 2|
Open phase II study.
Response rate for the combination of etoposide, oxaliplatin and capecitabine given every 3 weeks on an outpatient basis.
Secondary endpoint are safety, time to progression and survival
Etoposide are administered intravenously 100 mg/m2 on day 1 and orally 200 mg/m2 on days 2 and 3.
Capecitabine (Xeloda) are administered 1000 mg/m2 twice daily with 12 hours interval for two weeks and one week off
Oxaliplatin are administered intravenously 100 mg/m2 on day 1 in each cycle as a 2 hours infusion.
One cycle is 3 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC|
|Study Start Date :||February 2006|
|Actual Study Completion Date :||April 2007|
- Time to progression
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00351195
|Århus Sygehus, Dept. of Oncology|
|Århus, Denmark, 8000 C|
|Principal Investigator:||Ulrik Lassen, MD., PH.D.||Rigshospitalet, Dept. of Oncology|