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

NCT00351195 | Terminated Phase 2

• 1 other identifier: etoxel-01-2005
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinoma; Etoposide; Oxaliplatin; Capecitabine

Outcome Measures

Primary Outcomes (1)

• Response

Secondary Outcomes (3)

• Time to progression

• Safety

• Survival

Interventions

Etoposide DRUG

Oxaliplatin DRUG

Capecitabine DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus: collaborator

Study Sites (1)

Århus Sygehus, Dept. of Oncology

Aarhus, 8000 C, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Etoposide; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Coordination Complexes; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Ulrik Lassen, MD., PH.D.

  Rigshospitalet, Dept. of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 11, 2006
• First Posted: July 12, 2006
• Study Start: February 1, 2006
• Study Completion: April 1, 2007
• Last Updated: August 26, 2008

Record last verified: 2008-08

Locations

DK (1)