Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
NCT ID: NCT00004920
Last Updated: 2012-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
256 participants
INTERVENTIONAL
1999-11-30
Brief Summary
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PURPOSE: Randomized phase III trial to compare the effectiveness of cisplatin with or without raltitrexed in treating patients who have malignant mesothelioma of the pleura.
Detailed Description
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* Compare overall survival in patients with malignant pleural mesothelioma treated with raltitrexed with or without cisplatin.
* Assess toxicity, progression free survival, and quality of life with these treatment regimens in these patients.
* Evaluate objective response and duration of response to these treatment regimens in patients with measurable disease.
OUTLINE: 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.
* Arm I: Patients receive cisplatin IV over 1-2 hours on day 1.
* Arm II: Patients receive raltitrexed IV over 15 minutes followed by cisplatin IV over 1-2 hours on day 1.
Treatment continues every 3 weeks in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed before study, prior to each course, after the last course, and then every 6 weeks for 1 year.
Patients are followed every 6 weeks until death.
PROJECTED ACCRUAL: A total of 240 patients will be accrued for this study over 24 months.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cisplatin
raltitrexed
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed malignant pleural mesothelioma
* No CNS metastases
PATIENT CHARACTERISTICS:
Age:
* Over 18
Performance status:
* ZUBROD, ECOG, WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* Hemoglobin at least 10.0 g/dL
* WBC at least 4,000/mm\^3
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin less than 1.46 mg/dL
* Albumin at least 3.0 g/dL
* ALAT/ASAT less than 2.5 times upper limit of normal (ULN) (less than 5 times ULN if liver involvement)
Renal:
* Creatinine less than 1.69 mg/dL
* Creatinine clearance at least 65 mL/min
Cardiovascular:
* Not specified
Pulmonary:
* Not specified
Other:
* 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
* No prior malignant melanoma, hypernephroma or breast carcinoma
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after study
* No uncontrolled infections
* No psychological, familial, sociological, or geographical condition that precludes study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* No concurrent immunotherapy before first disease progression
Chemotherapy:
* No prior systemic or intracavitary cytotoxic chemotherapy
* No other prior or concurrent chemotherapy before first disease progression
* No prior or concurrent pleurodesis with cytotoxic drugs (e.g., bleomycin)
Endocrine therapy:
* No concurrent hormonal therapy except corticosteroids before first disease progression
Radiotherapy:
* At least 4 weeks since prior radiotherapy to target lesion and progression observed
* Concurrent palliative radiotherapy to painful lesions allowed only if target lesion outside of irradiated field
Surgery:
* Prior surgery allowed if followed by disease progression
Other:
* At least 1 month since prior investigational drugs
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Jan P. Van Meerbeeck, MD, PhD
Role: STUDY_CHAIR
University Medical Center Rotterdam at Erasmus Medical Center
Locations
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U.Z. Gasthuisberg
Leuven, , Belgium
Cancer Care Ontario-Hamilton Regional Cancer Centre
Hamilton, Ontario, Canada
Cancer Care Ontario-London Regional Cancer Centre
London, Ontario, Canada
Trillium Health Centre
Mississauga, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
McGill University
Montreal, Quebec, Canada
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada
National Cancer Institute of Egypt
Cairo, , Egypt
Assistance Publique Hopitaux de Marseille Hopitaux Sud
Marseille, , France
Hopital de la Conception
Marseille, , France
Hopital Charles Nicolle
Rouen, , France
Thoraxklinik Rohrbach
Heidelberg, , Germany
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), , Italy
University Medical Center Nijmegen
Nijmegen, , Netherlands
University Hospital - Rotterdam Dijkzigt
Rotterdam, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Academisch Ziekenhuis Utrecht
Utrecht, , Netherlands
Instituto de Enfermedades Neoplasicas
Lima, , Peru
Medical University of Gdansk
Gdansk, , Poland
Regional Lung Diseases Hospital
Poznan, , Poland
University Hospital
Basel, , Switzerland
Inselspital, Bern
Bern, , Switzerland
Kantonsspital - St. Gallen
Sankt Gallen, , Switzerland
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Weston Park Hospital
Sheffield, England, United Kingdom
Western General Hospital
Edinburgh, Scotland, United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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EORTC-08983
Identifier Type: -
Identifier Source: secondary_id
EORTC-08983
Identifier Type: -
Identifier Source: org_study_id