Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-01-22 @ 12:38 PM
Study NCT ID:
NCT00004920
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2000-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'C068874', 'term': 'raltitrexed'}], 'ancestors': [{'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 256}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'lastUpdateSubmitDate': '2012-07-17', 'studyFirstSubmitDate': '2000-03-07', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['localized malignant mesothelioma', 'advanced malignant mesothelioma', 'recurrent malignant mesothelioma'], 'conditions': ['Malignant Mesothelioma']}, 'referencesModule': {'references': [{'pmid': '16809726', 'type': 'BACKGROUND', 'citation': 'Francart J, Legrand C, Sylvester R, Van Glabbeke M, van Meerbeeck JP, Robert A. Progression-free survival rate as primary end point for phase II cancer clinical trials: application to mesothelioma--The EORTC Lung Cancer Group. J Clin Oncol. 2006 Jul 1;24(19):3007-12. doi: 10.1200/JCO.2005.05.1359.'}, {'pmid': '18089874', 'type': 'RESULT', 'citation': 'Bottomley A, Coens C, Efficace F, Gaafar R, Manegold C, Burgers S, Vincent M, Legrand C, van Meerbeeck JP; EORTC-NCIC. Symptoms and patient-reported well-being: do they predict survival in malignant pleural mesothelioma? A prognostic factor analysis of EORTC-NCIC 08983: randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma. J Clin Oncol. 2007 Dec 20;25(36):5770-6. doi: 10.1200/JCO.2007.12.5294.'}, {'pmid': '16446322', 'type': 'RESULT', 'citation': 'Bottomley A, Gaafar R, Manegold C, Burgers S, Coens C, Legrand C, Vincent M, Giaccone G, Van Meerbeeck J; EORTC Lung-Cancer Group; National Cancer Institute, Canada. Short-term treatment-related symptoms and quality of life: results from an international randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an EORTC Lung-Cancer Group and National Cancer Institute, Canada, Intergroup Study. J Clin Oncol. 2006 Mar 20;24(9):1435-42. doi: 10.1200/JCO.2005.03.3027. Epub 2006 Jan 30.'}, {'pmid': '16192580', 'type': 'RESULT', 'citation': 'van Meerbeeck JP, Gaafar R, Manegold C, Van Klaveren RJ, Van Marck EA, Vincent M, Legrand C, Bottomley A, Debruyne C, Giaccone G; European Organisation for Research and Treatment of Cancer Lung Cancer Group; National Cancer Institute of Canada. Randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an intergroup study of the European Organisation for Research and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada. J Clin Oncol. 2005 Oct 1;23(28):6881-9. doi: 10.1200/JCO.20005.14.589.'}, {'type': 'RESULT', 'citation': 'Van Meerbeeck JP, Manegold C, Gaafar R, et al.: A randomized phase III study of cisplatin with or without raltitrexed in patients (pts) with malignant pleural mesothelioma (MPM): an intergroup study of the EORTC Lung Cancer Group and NCIC. [Abstract] J Clin Oncol 22 (Suppl 14): A-7021, 622s, 2004.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether receiving cisplatin with raltitrexed is more effective than cisplatin alone for malignant mesothelioma.\n\nPURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without raltitrexed in treating patients who have malignant mesothelioma of the pleura.', 'detailedDescription': 'OBJECTIVES:\n\n* Compare overall survival in patients with malignant pleural mesothelioma treated with raltitrexed with or without cisplatin.\n* Assess toxicity, progression free survival, and quality of life with these treatment regimens in these patients.\n* Evaluate objective response and duration of response to these treatment regimens in patients with measurable disease.\n\nOUTLINE: This is a randomized, open, multicenter study. Patients are stratified according to performance status (0 vs 1-2) and WBC count (less than 8,300/mm3 vs 8,300/mm3 or more). Patients are randomized to one of two treatment arms.\n\n* Arm I: Patients receive cisplatin IV over 1-2 hours on day 1.\n* Arm II: Patients receive raltitrexed IV over 15 minutes followed by cisplatin IV over 1-2 hours on day 1.\n\nTreatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity.\n\nQuality of life is assessed before study, prior to each course, after the last course, and then every 6 weeks for 1 year.\n\nPatients are followed every 6 weeks until death.\n\nPROJECTED ACCRUAL: A total of 240 patients will be accrued for this study over 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed malignant pleural mesothelioma\n* No CNS metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Over 18\n\nPerformance status:\n\n* ZUBROD, ECOG, WHO 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Hemoglobin at least 10.0 g/dL\n* WBC at least 4,000/mm\\^3\n* Absolute neutrophil count at least 2,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin less than 1.46 mg/dL\n* Albumin at least 3.0 g/dL\n* ALAT/ASAT less than 2.5 times upper limit of normal (ULN) (less than 5 times ULN if liver involvement)\n\nRenal:\n\n* Creatinine less than 1.69 mg/dL\n* Creatinine clearance at least 65 mL/min\n\nCardiovascular:\n\n* Not specified\n\nPulmonary:\n\n* Not specified\n\nOther:\n\n* No other prior or concurrent malignancies within past 5 years except adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin\n* No prior malignant melanoma, hypernephroma or breast carcinoma\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception during and for 6 months after study\n* No uncontrolled infections\n* No psychological, familial, sociological, or geographical condition that precludes study compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No concurrent immunotherapy before first disease progression\n\nChemotherapy:\n\n* No prior systemic or intracavitary cytotoxic chemotherapy\n* No other prior or concurrent chemotherapy before first disease progression\n* No prior or concurrent pleurodesis with cytotoxic drugs (e.g., bleomycin)\n\nEndocrine therapy:\n\n* No concurrent hormonal therapy except corticosteroids before first disease progression\n\nRadiotherapy:\n\n* At least 4 weeks since prior radiotherapy to target lesion and progression observed\n* Concurrent palliative radiotherapy to painful lesions allowed only if target lesion outside of irradiated field\n\nSurgery:\n\n* Prior surgery allowed if followed by disease progression\n\nOther:\n\n* At least 1 month since prior investigational drugs'}, 'identificationModule': {'nctId': 'NCT00004920', 'briefTitle': 'Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma', 'orgStudyIdInfo': {'id': 'EORTC-08983'}, 'secondaryIdInfos': [{'id': 'EORTC-08983'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'cisplatin', 'type': 'DRUG'}, {'name': 'raltitrexed', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': 'L8V 5C2', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Care Ontario-Hamilton Regional Cancer Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'zip': 'N6A 4L6', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Cancer Care Ontario-London Regional Cancer Centre', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'L5B 1B8', 'city': 'Mississauga', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Trillium Health Centre', 'geoPoint': {'lat': 43.5789, 'lon': -79.6583}}, {'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H2W 1S6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'S4T 7T1', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Allan Blair Cancer Centre', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'National Cancer Institute of Egypt', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '13274', 'city': 'Marseille', 'country': 'France', 'facility': 'Assistance Publique Hopitaux de Marseille Hopitaux Sud', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13385', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital de la Conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Hopital Charles Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': 'D-69126', 'city': 'Heidelberg', 'country': 'Germany', 'facility': 'Thoraxklinik Rohrbach', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}, {'zip': '16132', 'city': 'Genoa (Genova)', 'country': 'Italy', 'facility': 'Istituto Nazionale per la Ricerca sul Cancro', 'geoPoint': {'lat': 44.40478, 'lon': 8.94439}}, {'zip': 'NL-6500 HB', 'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'University Medical Center Nijmegen', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'zip': '3000 CA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'University Hospital - Rotterdam Dijkzigt', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3075 EA', 'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus Medical Center', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Academisch Ziekenhuis Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': '34', 'city': 'Lima', 'country': 'Peru', 'facility': 'Instituto de Enfermedades Neoplasicas', 'geoPoint': {'lat': -12.04318, 'lon': -77.02824}}, {'zip': '80-211', 'city': 'Gdansk', 'country': 'Poland', 'facility': 'Medical University of Gdansk', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '60 569', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Regional Lung Diseases Hospital', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}, {'zip': 'CH-4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': 'CH-3010', 'city': 'Bern', 'country': 'Switzerland', 'facility': 'Inselspital, Bern', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': 'CH-9007', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'Kantonsspital - St. Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': 'NG5 1PB', 'city': 'Nottingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Nottingham City Hospital NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}, {'zip': 'S1O 2SJ', 'city': 'Sheffield', 'state': 'England', 'country': 'United Kingdom', 'facility': 'Weston Park Hospital', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}, {'zip': 'EH4 2XU', 'city': 'Edinburgh', 'state': 'Scotland', 'country': 'United Kingdom', 'facility': 'Western General Hospital', 'geoPoint': {'lat': 55.95206, 'lon': -3.19648}}], 'overallOfficials': [{'name': 'Jan P. Van Meerbeeck, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Medical Center Rotterdam at Erasmus Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}