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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00351195
Recruitment Status : Terminated (Did not meet the criteria for continuation to second stage)
First Posted : July 12, 2006
Last Update Posted : August 26, 2008
Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus
Information provided by:
Rigshospitalet, Denmark

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 agents etoposide, oxaliplatin and capecitabine each has sparse efficacy as single agents, but the combination may act synergistically with an acceptable toxicity profile.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Drug: Etoposide Drug: Oxaliplatin Drug: Capecitabine Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
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
Study Start Date : February 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Response

Secondary Outcome Measures :
  1. Time to progression
  2. Safety
  3. Survival

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00351195

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Århus Sygehus, Dept. of Oncology
Århus, Denmark, 8000 C
Sponsors and Collaborators
Rigshospitalet, Denmark
Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus
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Principal Investigator: Ulrik Lassen, MD., PH.D. Rigshospitalet, Dept. of Oncology

Layout table for additonal information Identifier: NCT00351195     History of Changes
Other Study ID Numbers: etoxel-01-2005
First Posted: July 12, 2006    Key Record Dates
Last Update Posted: August 26, 2008
Last Verified: August 2008

Keywords provided by Rigshospitalet, Denmark:
Hepatocellular carcinoma

Additional relevant MeSH terms:
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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