Raltitrexed in Treating Patients With Malignant Mesothelioma That Cannot Be Surgically Removed
NCT ID: NCT00004254
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
PHASE2
25 participants
INTERVENTIONAL
1999-11-30
Brief Summary
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PURPOSE: Phase II trial to study the effectiveness of raltitrexed in treating patients who have malignant mesothelioma that cannot be surgically removed.
Detailed Description
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OUTLINE: This is a multicenter study. Within 2 weeks of staging procedures, patients receive raltitrexed IV over 15 minutes on day 1. Treatment repeats every 3 weeks for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression and then every 8 weeks thereafter for survival.
PROJECTED ACCRUAL: A total of 24 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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raltitrexed
Eligibility Criteria
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Inclusion Criteria
PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent anticancer immunotherapy before first disease progression Chemotherapy: No prior systemic or intracavitary cytotoxic drugs No concurrent intrapleural or other systemic cytotoxic drugs Endocrine therapy: No concurrent anticancer hormonal agents (except corticosteroids) before first disease progression Radiotherapy: See Disease Characteristics Concurrent palliative radiotherapy allowed for painful lesions, needle tracts, or surgical scars or prevention of metastases along biopsy tracks At least 4 weeks since prior radiotherapy No prior radiotherapy to sole indicator lesion unless lesion is clearly progressive Surgery: See Disease Characteristics Prior pleurodesis allowed except with cytotoxic drugs (e.g., bleomycin) Concurrent pleurodesis with noncytotoxic drugs allowed Other: At least 1 month since other prior investigational agent No other concurrent anticancer agents before first disease progression
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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Giuseppe Giaccone, MD, PhD
Role: STUDY_CHAIR
Free University Medical Center
Locations
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Ospedale Bellaria
Bologna, , Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa, , Italy
Istituto Nazionale per lo Studio e la Cura dei Tumori
Naples, , Italy
Universita Degli Studi di Udine
Udine, , Italy
Antoni van Leeuwenhoekhuis
Amsterdam, , Netherlands
Vrije Universiteit Medisch Centrum
Amsterdam, , Netherlands
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.
Baas P, Ardizzoni A, Grossi F, Nackaerts K, Numico G, Van Marck E, van de Vijver M, Monetti F, Smid-Geirnaerdt MJ, van Zandwijk N, Debruyne C, Legrand C, Giaccone G; EORTC Lung Cancer Group. The activity of raltitrexed (Tomudex) in malignant pleural mesothelioma: an EORTC phase II study (08992). Eur J Cancer. 2003 Feb;39(3):353-7. doi: 10.1016/s0959-8049(02)00668-8.
Other Identifiers
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EORTC-08992
Identifier Type: -
Identifier Source: secondary_id
EORTC-08992
Identifier Type: -
Identifier Source: org_study_id