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

Sponsor

Rigshospitalet, Denmark (Other)

Overall Status

Terminated

CT.gov ID

NCT00351195

Collaborator

Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus (Other)

Enrollment

Location

13.9

Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Feb 1, 2006

Actual Study Completion Date :

Apr 1, 2007

Outcome Measures

Primary Outcome Measures

Response []

Secondary Outcome Measures

Time to progression []
Safety []
Survival []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.