Status:
TERMINATED
Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC)
Lead Sponsor:
Rigshospitalet, Denmark
Collaborating Sponsors:
Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus
Conditions:
Hepatocellular Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 ag...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT00351195
Start Date
February 1 2006
End Date
April 1 2007
Last Update
August 26 2008
Active Locations (1)
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1
Århus Sygehus, Dept. of Oncology
Aarhus, Denmark, 8000 C