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

NCT ID: NCT00351195

Last Updated: 2008-08-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2007-04-30

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.

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Etoposide; Oxaliplatin; Capecitabine

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Etoposide

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus

UNKNOWN

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Principal Investigators

Ulrik Lassen, MD., PH.D.

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Dept. of Oncology

Locations

Århus Sygehus, Dept. of Oncology

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

etoxel-01-2005

Identifier Type: -

Identifier Source: org_study_id