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Sponsors and Collaborators: |
Rigshospitalet, Denmark Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus |
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Information provided by: | Rigshospitalet, Denmark |
ClinicalTrials.gov Identifier: | NCT00351195 |
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 | Intervention | Phase |
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Hepatocellular Carcinoma |
Drug: Etoposide Drug: Oxaliplatin Drug: Capecitabine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC |
Estimated Enrollment: | 39 |
Study Start Date: | February 2006 |
Study Completion Date: | April 2007 |
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.
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Denmark | |
Århus Sygehus, Dept. of Oncology | |
Århus, Denmark, 8000 C |
Principal Investigator: | Ulrik Lassen, MD., PH.D. | Rigshospitalet, Dept. of Oncology |
Study ID Numbers: | etoxel-01-2005 |
Study First Received: | July 11, 2006 |
Last Updated: | August 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00351195 |
Health Authority: | Denmark: Danish Medicines Agency |
Hepatocellular carcinoma Etoposide Oxaliplatin Capecitabine |
Liver Diseases Capecitabine Digestive System Neoplasms Carcinoma, Hepatocellular Liver neoplasms Etoposide phosphate Carcinoma Liver Neoplasms |
Oxaliplatin Digestive System Diseases Gastrointestinal Neoplasms Adenocarcinoma Etoposide Neoplasms, Glandular and Epithelial Hepatocellular carcinoma |
Antimetabolites Neoplasms Antimetabolites, Antineoplastic Neoplasms by Site Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Therapeutic Uses Antineoplastic Agents, Phytogenic Pharmacologic Actions |