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

Hepatocellular Carcinoma Clinical Trial

Official title:

A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00351195
• Other study ID #: etoxel-01-2005
• Status: Terminated
• Phase: Phase 2
• First received: July 11, 2006
• Last updated: August 25, 2008
• Start date: February 2006
• Est. completion date: April 2007

Study information

• Verified date: August 2008
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 39
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• Etoposide

• Oxaliplatin

• Capecitabine

Locations

Country	Name	City	State
Denmark	Århus Sygehus, Dept. of Oncology	Århus

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response
Secondary	Time to progression
Secondary	Safety
Secondary	Survival