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

• Status: Terminated
• Trial end date: 2007-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborator: Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus
• Treatments: Capecitabine; Etoposide; Etoposide phosphate; Oxaliplatin

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.