Ignite Creation Date:
2025-12-24 @ 9:34 PM
Ignite Modification Date:
2025-12-25 @ 7:18 PM
Study NCT ID:
NCT01243632
Status:
COMPLETED
Last Update Posted:
2010-11-18
First Post:
2010-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086002', 'term': 'Mesothelioma, Malignant'}], 'ancestors': [{'id': 'D008654', 'term': 'Mesothelioma'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018301', 'term': 'Neoplasms, Mesothelial'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010997', 'term': 'Pleural Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 78}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-17', 'studyFirstSubmitDate': '2010-11-10', 'studyFirstSubmitQcDate': '2010-11-17', 'lastUpdatePostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response rate', 'timeFrame': 'Computerized tomography (CT) measurement of disease will be performed after 2nd cycle of chemotherapy and at the end of the treatment', 'description': 'Efficacy of the treatment will be measured by response rate (RR) and disease control rate (DCR) using modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria for assessment of response in malignant pleural mesothelioma'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability', 'timeFrame': 'During the study', 'description': 'Safety and tolerability will be assessed by monitoring the adverse events during treatment and follow-up phase and graded according the NCI Common Toxicity Criteria (CTC), version 2.0. Participants will be followed until death or 2 to 7 years (average 4.5 years).'}]}, 'conditionsModule': {'keywords': ['malignant pleural mesothelioma', 'chemotherapy', 'gemcitabine', 'cisplatin', 'long infusion'], 'conditions': ['Malignant Pleural Mesothelioma']}, 'descriptionModule': {'briefSummary': 'Combination of gemcitabine-cisplatin was one of the most effective chemotherapy treatment in mesothelioma patients. However, median survival of this patient group was only about 12 months. With intent to find more effective treatment the investigators performed phase II study with gemcitabine in low dose (130-250 mg/m2) in 6-hours (prolonged) infusion in combination with cisplatin in advanced non-small cell lung cancer (Zwitter et al. Anticancer Drugs 2005;16:1129-34). After favourable experience, the investigators decided to explore such regiment in patients with malignant pleural mesothelioma (MPM) as well.', 'detailedDescription': 'The purpose of this study is to evaluate new regimen of treatment for its activity in malignant pleural mesothelioma (MPM). The primary objectives of the trial are assessing the treatment toxicity, response rate, and progress free survival; secondary objectives are assessment of overall survival and quality of life.\n\nInclusion criteria:\n\n* Biopsy-proven diagnosis of MPM\n* Inoperable for anatomic or physiological reason\n* Measurable and previously unirradiated lesion\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2\n* Adequate haematopoietic, liver, and kidney function.\n* Signed informed consent for participation in the trial\n\nExclusion criteria:\n\n* Significant medical co-morbidity\n* Pregnant or lactating women\n* History of the cancer in the previous 10 years or breast cancer ever.\n\nThe general treatment schedule will be identical for all patients: gemcitabine in 6-hours infusion on days 1 and 8, and cisplatin at 75 mg/m2 on day 2 of a 3-weekly cycle with standard antiemetic treatment using metoclopramide, dexamethasone, aprepitant, and granisetron. After 4 cycles, patients not in progression and without serious toxicity continued with additional 2 cycles of monotherapy with gemcitabine in prolonged infusion.\n\nNational Cancer Institute Common Toxicity Criteria (NCI CTC), version 2.0 will be used for grading the toxicity. In the day of administration of the cytotoxic drug complete blood cell count and chemistry panel will be performed, and the treatment will be reduced or avoided in the event of bone marrow suppression or decline in renal clearance. In cases of Grade I (NCI CTC, vs. 2.0) neutropenia and/or thrombocytopenia, the dose of gemcitabine will be reduced to 75%; the drug will be omitted with Grade II or greater neutro/thrombocytopenia. Cisplatin will be omitted in cases of Grade ≥ II nephrotoxicity and/or grade III nausea or vomiting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biopsy-proven diagnosis of malignant pleural mesothelioma\n* Inoperable for anatomic or physiological reason\n* Measurable and previously unirradiated lesion\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 - 2\n* Adequate haematopoietic, liver, and kidney function.\n* Signed informed consent for participation in the trial\n\nExclusion Criteria:\n\n* Significant medical co-morbidity\n* Pregnant or lactating women\n* History of the cancer in the previous 10 years or breast cancer ever.'}, 'identificationModule': {'nctId': 'NCT01243632', 'briefTitle': 'Gemcitabine in Long Infusion and Cisplatin for Malignant Pleural Mesothelioma Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Institute of Oncology Ljubljana'}, 'officialTitle': 'A Phase II Trial of Low-dose Gemcitabine in Prolonged Infusion and Cisplatin in Treatment of Malignant Pleural Mesothelioma', 'orgStudyIdInfo': {'id': '86/12/02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Prolonged 6-hr infusion of gemcitabine', 'type': 'DRUG', 'description': 'Gemcitabine 250 mg/m2 in prolonged 6 hr infusion on day 1 and 8, and cisplatin at 75 mg/m2 on day 2 of 3 week cycle, for 4-6 cycles'}]}, 'contactsLocationsModule': {'locations': [{'zip': '1000', 'city': 'Ljubljana', 'country': 'Slovenia', 'facility': 'Institute of Oncology Ljubljana', 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}], 'overallOfficials': [{'name': 'Matjaz Zwitter, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Institute of Oncology Ljubljana'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute of Oncology Ljubljana', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Higher Education, Science and Technology, Solvenia', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Viljem Kovac, MD, Head of the Mesothelioma Team', 'oldOrganization': 'Institute of Oncology Ljubljana'}}}}