A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC
18 Years
75 Years
Both
Hepatocellular Carcinoma
Trial Information
A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC
Design:
Open phase II study.
Purpose:
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
Treatment:
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.
Inclusion Criteria:
- Histologically verified intra- or extrahepatic inoperable hepatocellular carcinoma or
hyperdense liver lesion at computed tomography and concurrent elevated
alpha-feto-protein > 400 ng/ml
- PS 0-2
- Age 18-75
- Life expectancy > 12 weeks
- Normal bone marrow function (neutrophiles > 1,5 x 109/l and platelets > 100 x 109/l)
- Bilirubin < 2 x UNL
- Transaminases < 3 x UNL
- Normal renal function, Cr-EDTA clearance > 50 ml/min
- No chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
- No uncontrolled, severe concurrent medical disease
- Fertile women must have a negative pregnancy test
- Fertile women must use adequate contraceptives during and 3 months after trial
exposure
- Signed informed consent
Exclusion Criteria:
- Chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion
- Experimental therapy < 8 weeks prior to inclusion
- Known DPD-deficiency
- Known neuropathy
- Uncontrolled, severe concurrent medical disease
- Prior malignancy during the last 5 years, except for non-melanoma skin cancer and
carcinoma in situ cervix uteri.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response
Principal Investigator
Ulrik Lassen, MD., PH.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Rigshospitalet, Dept. of Oncology
Authority:
Denmark: Danish Medicines Agency
Study ID:
etoxel-01-2005
NCT ID:
NCT00351195
Start Date:
February 2006
Completion Date:
April 2007
Related Keywords:
- Hepatocellular Carcinoma
- Hepatocellular carcinoma
- Etoposide
- Oxaliplatin
- Capecitabine
- Carcinoma
- Carcinoma, Hepatocellular
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