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TerminatedNCT00351195Updated Aug 26, 2008

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

A Phase 2 interventional study of Etoposide and Oxaliplatin in Hepatocellular Carcinoma, sponsored by Rigshospitalet, Denmark. Terminated at 1 site in Denmark. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-08-26.

Sponsored by Rigshospitalet, Denmark · Phase 2, Interventional, and Treatment

Why this study was terminated
Did not meet the criteria for continuation to second stage
Phase
Phase 2
Study type
Interventional
Enrollment
39
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hepatocellular Carcinoma

Keywords

  • Hepatocellular carcinoma
  • Etoposide
  • Oxaliplatin
  • Capecitabine
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 39 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Rigshospitalet, Denmark is the lead sponsor of 1,017 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
39 participants (estimated)

Interventions

  • DrugEtoposide
  • DrugOxaliplatin
  • DrugCapecitabine
06

What researchers measure

Primary outcomes

  1. Response

Secondary outcomes

  1. Time to progression

  2. Safety

  3. Survival

07

Study locations

1 site
  • Århus Sygehus, Dept. of Oncology
    Århus, 8000 C, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 26, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00351195
Lead sponsor
Rigshospitalet, Denmark
Collaborators
Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus
First posted
Jul 12, 2006
Start date
Feb 2006
Completion
Apr 2007
Last update
Aug 26, 2008

Study contacts

Ulrik Lassen, MD., PH.D.
principal investigator · Rigshospitalet, Dept. of Oncology
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.

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