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

This study has been terminated.
(Did not meet the criteria for continuation to second stage)
Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus
Information provided by:
Rigshospitalet, Denmark Identifier:
First received: July 11, 2006
Last updated: August 25, 2008
Last verified: August 2008
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.

Condition Intervention Phase
Hepatocellular Carcinoma Drug: Etoposide Drug: Oxaliplatin Drug: Capecitabine Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Response

Secondary Outcome Measures:
  • Time to progression
  • Safety
  • Survival

Estimated Enrollment: 39
Study Start Date: February 2006
Study Completion Date: April 2007
Detailed Description:


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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00351195

Århus Sygehus, Dept. of Oncology
Århus, Denmark, 8000 C
Sponsors and Collaborators
Rigshospitalet, Denmark
Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus
Principal Investigator: Ulrik Lassen, MD., PH.D. Rigshospitalet, Dept. of Oncology
  More Information Identifier: NCT00351195     History of Changes
Other Study ID Numbers: etoxel-01-2005
Study First Received: July 11, 2006
Last Updated: August 25, 2008

Keywords provided by Rigshospitalet, Denmark:
Hepatocellular carcinoma

Additional relevant MeSH terms:
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Etoposide phosphate
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on September 21, 2017