Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT01079767
Status:
TERMINATED
Last Update Posted:
2014-03-04
First Post:
2010-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C401859', 'term': 'temsirolimus'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'The study treminated early according to DSMB recommendantions', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'lastUpdateSubmitDate': '2014-03-03', 'studyFirstSubmitDate': '2010-03-02', 'studyFirstSubmitQcDate': '2010-03-02', 'lastUpdatePostDateStruct': {'date': '2014-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-month disease-control rate according to RECIST criteria', 'timeFrame': '2010'}], 'secondaryOutcomes': [{'measure': '3-month objective response rate according to RECIST criteria', 'timeFrame': '2010'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['adult primary hepatocellular carcinoma', 'advanced adult primary liver cancer', 'localized unresectable adult primary liver cancer', 'recurrent adult primary liver cancer'], 'conditions': ['Liver Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Temsirolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.\n\nPURPOSE: This phase II trial is studying how well temsirolimus works in treating patients with advanced liver cancer and cirrhosis.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* To determine the 3-month disease-control rate according to RECIST criteria in patients with advanced hepatocellular carcinoma and Child-Pugh class B cirrhosis.\n\nSecondary\n\n* To determine the 3-month objective response rate according to RECIST criteria in these patients.\n* To determine the 1-month metabolic response rate on PET/CT scan in these patients.\n* To determine the 1-month perfusion response rate on hepatic perfusion CT scan in these patients.\n* To determine the time to progression in patients treated with this drug.\n* To determine the progression-free survival of patients treated with this drug.\n* To determine the overall survival of patients treated with this drug.\n* To assess quality of life according to QLQ-C30 and QLQ-HCC18 questionnaires.\n* To determine the clinical and biological tolerance of this drug in these patients.\n* To determine the rate of m-TOR pathway activation and VEGF level.\n* To evaluate the pharmacokinetics of this drug in select patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive temsirolimus IV over 30-60 minutes on day 1. Treatment repeats once a week in the absence of disease progression or unacceptable toxicity. Patients also undergo fludeoxyglucose F 18 (FDG) positron emission tomography/computed tomography (PET/CT) scan and perfusion CT scan of the liver at baseline and periodically during study treatment.\n\nPatients complete quality of life questionnaires (QLC-C30 and QLQ-HCC18) periodically. Some patients undergo blood and tissue sample collection periodically for pharmacological and laboratory studies.\n\nAfter completion of study therapy, patients are followed for up to 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of hepatocellular carcinoma (HCC) according to the European Association for the Study of the Liver (EASL) criteria\n\n * Advanced disease\n * Must be morphologically evaluable\n* HCC not accessible to other treatment (e.g., surgery, radiofrequency, or chemoembolization) and can not benefit from antiangiogenic therapy\n* CLIP score ≤ 3 (except for patients with tumors invading more than 50% of tumor volume)\n* Child-Pugh cirrhosis score between B7 and B9, meeting the following criteria:\n\n * Diagnosed clinically, biologically (e.g., prothrombin time, platelets, or albumin), endoscopically (signs of portal hypertension) and morphologically (dysmorphic liver on ultrasound or CT scan), or by liver biopsy\n* Not a candidate for transplantation and has not received a liver transplant\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Life expectancy ≥ 3 months\n* Platelet count ≥ 50,000/mm\\^3\n* Neutrophil count ≥ 1,500/mm\\^3\n* Creatinine clearance ≥ 60 mL/min\n* GFR ≥ 30 mL/min\n* Serum cholesterol ≤ 350 mg/dL\n* Triglycerides ≤ 300 mg/dL\n* Not pregnant or nursing\n* Fertile patients must use effective contraception during and for more than 2 months after completion of study therapy\n* No history of other cancer on treatment\n* No cardiopulmonary disease impairment, including a history of stable or unstable angina or myocardial infarction\n* No active infection except for viral hepatitis\n* No HIV positivity\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics\n* At least 2 weeks since prior inhibitors or inducers of P-glycoprotein, CYP3A4, or CYP3A5\n* At least 4 weeks since prior surgery, radiotherapy (except radiotherapy to the bone), transarterial chemoembolization, immunotherapy, or other investigational drug for HCC\n* At least 6 months since prior chemotherapy'}, 'identificationModule': {'nctId': 'NCT01079767', 'briefTitle': 'Temsirolimus in Treating Patients With Advanced Liver Cancer and Cirrhosis', 'organization': {'class': 'OTHER', 'fullName': 'Federation Francophone de Cancerologie Digestive'}, 'officialTitle': 'Advanced Hepatocellular Carcinoma on Child B Cirrhosis: Tolerance and Efficacy of Torisel® (Temsirolimus)', 'orgStudyIdInfo': {'id': 'CDR0000666229'}, 'secondaryIdInfos': [{'id': 'FFCD-0903'}, {'id': 'EUDRACT-2009-014443-36'}, {'id': 'EU-21004'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Temsirolimus', 'description': 'Temsirolimus', 'interventionNames': ['Drug: temsirolimus']}], 'interventions': [{'name': 'temsirolimus', 'type': 'DRUG', 'armGroupLabels': ['Temsirolimus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}], 'overallOfficials': [{'name': 'Thomas Decaens, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Henri Mondor'}, {'name': 'Christophe Duvoux', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire Henri Mondor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federation Francophone de Cancerologie Digestive', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}