Clinical trial NCT00351195: Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC)
Official title: A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Etoposide
Oxaliplatin
Capecitabine
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus
First posted: 2006-07-12
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Response
Secondary outcomes:
measure: Time to progression
measure: Safety
measure: Survival
Other outcomes:
Locations:
city: Århus
country: Denmark
facility: Århus Sygehus, Dept. of Oncology
Study officials:
affiliation: Rigshospitalet, Dept. of Oncology
name: Ulrik Lassen, MD., PH.D.
role: PRINCIPAL_INVESTIGATOR
References: