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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)
Sponsor:
Collaborator:
Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00351195
First received: July 11, 2006
Last updated: August 25, 2008
Last verified: August 2008
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351195

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

No publications provided

ClinicalTrials.gov Identifier: NCT00351195     History of Changes
Other Study ID Numbers: etoxel-01-2005
Study First Received: July 11, 2006
Last Updated: August 25, 2008
Health Authority: Denmark: Danish Medicines Agency

Keywords provided by Rigshospitalet, Denmark:
Hepatocellular carcinoma
Etoposide
Oxaliplatin
Capecitabine

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Adenocarcinoma
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Liver Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Capecitabine
Etoposide
Etoposide phosphate
Fluorouracil
Oxaliplatin
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on November 25, 2014