Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC)
Various cytotoxic agents have been evaluated in advanced hepatocellular carcinoma, but response rates have been low with significant toxicity, most often due to parenchymal liver disease. The three agents etoposide, oxaliplatin and capecitabine each has sparse efficacy as single agents, but the combination may act synergistically with an acceptable toxicity profile.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC|
- Time to progression
|Study Start Date:||February 2006|
|Study Completion Date:||April 2007|
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.
|Århus Sygehus, Dept. of Oncology|
|Århus, Denmark, 8000 C|
|Principal Investigator:||Ulrik Lassen, MD., PH.D.||Rigshospitalet, Dept. of Oncology|