Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC) - Full Text View

Sponsors and Collaborators:	Rigshospitalet, Denmark Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus
Information provided by:	Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:	NCT00351195

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 II

Drug Information available for: Etoposide Capecitabine Etoposide phosphate Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC

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

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

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

Keywords provided by Rigshospitalet, Denmark:

Hepatocellular carcinoma
Etoposide
Oxaliplatin
Capecitabine

Study placed in the following topic categories:

Liver Diseases
Capecitabine
Digestive System Neoplasms
Carcinoma, Hepatocellular
Liver neoplasms
Etoposide phosphate
Carcinoma
Liver Neoplasms

Oxaliplatin
Digestive System Diseases
Gastrointestinal Neoplasms
Adenocarcinoma
Etoposide
Neoplasms, Glandular and Epithelial
Hepatocellular carcinoma

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site
Neoplasms by Histologic Type

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009