Spots Global Cancer Trial Database for Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
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Trial Identification
Brief Title: Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
Official Title: Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma
Study ID: NCT00004920
Conditions
Study Description
Brief Summary: 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. 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: OBJECTIVES: * 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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, St. 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
Contact Details
Name: Jan P. Van Meerbeeck, MD, PhD
Affiliation: University Medical Center Rotterdam at Erasmus Medical Center
Role: STUDY_CHAIR
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