Ignite Creation Date:
2025-12-25 @ 4:56 AM
Ignite Modification Date:
2025-12-26 @ 3:56 AM
Study NCT ID:
NCT00280618
Status:
COMPLETED
Last Update Posted:
2009-09-15
First Post:
2006-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oxaliplatin in Unresectable Hepatocellular Carcinoma
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': 'D000077150', 'term': 'Oxaliplatin'}], 'ancestors': [{'id': 'D056831', 'term': 'Coordination Complexes'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'lastUpdateSubmitDate': '2009-09-14', 'studyFirstSubmitDate': '2006-01-20', 'studyFirstSubmitQcDate': '2006-01-20', 'lastUpdatePostDateStruct': {'date': '2009-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-01-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST', 'timeFrame': 'During the Study Conduct'}], 'secondaryOutcomes': [{'measure': 'Adverse Events collections and evaluation', 'timeFrame': 'From the signature of the informed consent up to the end of the study'}]}, 'conditionsModule': {'conditions': ['Carcinoma, Hepatocellular']}, 'descriptionModule': {'briefSummary': 'Primary:\n\n* To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin\n\nSecondary:\n\n* Safety and tolerability of this regimen in these patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients must have histologically confirmed hepatocellular carcinoma\n* Patients must have measurable disease by CT scan\n* Patients with unresectable, recurrent or metastatic disease may be chemonaive or may be previously treated by chemotherapy.\n* The period of washout of prior chemotherapy must be greater than 4 weeks from date of randomization. The prior chemotherapy should not include platinum compounds.\n* WHO performance status: 0 to 2\n* Patients must have adequate organ and marrow function as defined below:\n\n * Leukocytes : ≥ 3,000/μl\n * Absolute neutrophil count :≥ 1,500/μl\n * Platelets : ≥ 80,000/μl\n * Total bilirubin : \\< 3.0g/dl\n * ASAT/ALAT : ≤ 3 times the upper normal limits of the institute\n * Creatinine : \\< 120μmol/l\n* Patients with no evidence of clinically significant neuropathy.\n\nExclusion Criteria:\n\n* Documented allergy to platinum compound or to others study's drugs\n* Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)\n* Hematological disorder or malignancies\n* Metastasis to central nervous system\n* Other serious illness or medical conditions:\n\n * Active infectious disease\n * Congestive heart failure, or angina pectoris. Previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or arrhythmia.\n* Concurrent treatment with any other anticancer therapy\n* Concurrent treatment with other experimental drugs.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT00280618', 'briefTitle': 'Oxaliplatin in Unresectable Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Phase II Study of Eloxatin + 5-Fluorouracil/Leucovorin in Patients With Unresectable Hepatocellular Carcinoma', 'orgStudyIdInfo': {'id': 'L_9202'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Oxaliplatin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Pingkuan Zhang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Medical Affairs Study Director', 'oldOrganization': 'sanofi-aventis'}}}}