Ignite Creation Date:
2025-12-24 @ 2:09 PM
Ignite Modification Date:
2025-12-27 @ 10:43 PM
Study NCT ID:
NCT00351195
Status:
TERMINATED
Last Update Posted:
2008-08-26
First Post:
2006-07-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005047', 'term': 'Etoposide'}, {'id': 'D000077150', 'term': 'Oxaliplatin'}, {'id': 'D000069287', 'term': 'Capecitabine'}], 'ancestors': [{'id': 'D011034', 'term': 'Podophyllotoxin'}, {'id': 'D013764', 'term': 'Tetrahydronaphthalenes'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D005960', 'term': 'Glucosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D003841', 'term': 'Deoxycytidine'}, {'id': 'D003562', 'term': 'Cytidine'}, {'id': 'D011741', 'term': 'Pyrimidine Nucleosides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005472', 'term': 'Fluorouracil'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D003853', 'term': 'Deoxyribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 39}}, 'statusModule': {'whyStopped': 'Did not meet the criteria for continuation to second stage', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-25', 'studyFirstSubmitDate': '2006-07-11', 'studyFirstSubmitQcDate': '2006-07-11', 'lastUpdatePostDateStruct': {'date': '2008-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response'}], 'secondaryOutcomes': [{'measure': 'Time to progression'}, {'measure': 'Safety'}, {'measure': 'Survival'}]}, 'conditionsModule': {'keywords': ['Hepatocellular carcinoma', 'Etoposide', 'Oxaliplatin', 'Capecitabine'], 'conditions': ['Hepatocellular Carcinoma']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Design:\n\nOpen phase II study.\n\nPurpose:\n\nResponse rate for the combination of etoposide, oxaliplatin and capecitabine given every 3 weeks on an outpatient basis.\n\nSecondary endpoint are safety, time to progression and survival\n\nTreatment:\n\nEtoposide are administered intravenously 100 mg/m2 on day 1 and orally 200 mg/m2 on days 2 and 3.\n\nCapecitabine (Xeloda) are administered 1000 mg/m2 twice daily with 12 hours interval for two weeks and one week off\n\nOxaliplatin are administered intravenously 100 mg/m2 on day 1 in each cycle as a 2 hours infusion.\n\nOne cycle is 3 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically verified intra- or extrahepatic inoperable hepatocellular carcinoma or hyperdense liver lesion at computed tomography and concurrent elevated alpha-feto-protein \\> 400 ng/ml\n* PS 0-2\n* Age 18-75\n* Life expectancy \\> 12 weeks\n* Normal bone marrow function (neutrophiles \\> 1,5 x 109/l and platelets \\> 100 x 109/l)\n* Bilirubin \\< 2 x UNL\n* Transaminases \\< 3 x UNL\n* Normal renal function, Cr-EDTA clearance \\> 50 ml/min\n* No chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion\n* No uncontrolled, severe concurrent medical disease\n* Fertile women must have a negative pregnancy test\n* Fertile women must use adequate contraceptives during and 3 months after trial exposure\n* Signed informed consent\n\nExclusion Criteria:\n\n* Chemotherapy, radiotherapy or immunotherapy 4 weeks prior to inclusion\n* Experimental therapy \\< 8 weeks prior to inclusion\n* Known DPD-deficiency\n* Known neuropathy\n* Uncontrolled, severe concurrent medical disease\n* Prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.'}, 'identificationModule': {'nctId': 'NCT00351195', 'briefTitle': 'Etoposide, Oxaliplatin and Capecitabine in Advanced Hepatocellular Carcinoma (HCC)', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'A Phase II Study of Etoposide, Oxaliplatin and Capecitabine in Patients With Advanced HCC', 'orgStudyIdInfo': {'id': 'etoxel-01-2005'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Etoposide', 'type': 'DRUG'}, {'name': 'Oxaliplatin', 'type': 'DRUG'}, {'name': 'Capecitabine', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000 C', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Århus Sygehus, Dept. of Oncology', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Ulrik Lassen, MD., PH.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Dept. of Oncology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Morten Ladekarl, MD, DMSc., Dept. of Oncology, Århus Sygehus, Århus', 'class': 'UNKNOWN'}]}}}