Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Drug: Etoposide
* Drug: Oxaliplatin
* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Etoposide|nan|
|Drug: Oxaliplatin|nan|
|Drug: Capecitabine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Safety |  |  | 
| Survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatocellular carcinoma, Etoposide, Oxaliplatin, Capecitabine