Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
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.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma|
|Study Start Date:||November 1999|
|Primary Completion Date:||January 2003 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004920
Hide Study Locations
|Leuven, Belgium, B-3000|
|Cancer Care Ontario-Hamilton Regional Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Cancer Care Ontario-London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Trillium Health Centre|
|Mississauga, Ontario, Canada, L5B 1B8|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Montreal, Quebec, Canada, H2W 1S6|
|Allan Blair Cancer Centre|
|Regina, Saskatchewan, Canada, S4T 7T1|
|National Cancer Institute of Egypt|
|Assistance Publique Hopitaux de Marseille Hopitaux Sud|
|Marseille, France, 13274|
|Hopital de la Conception|
|Marseille, France, 13385|
|Hopital Charles Nicolle|
|Rouen, France, 76031|
|Heidelberg, Germany, D-69126|
|Istituto Nazionale per la Ricerca sul Cancro|
|Genoa (Genova), Italy, 16132|
|University Medical Center Nijmegen|
|Nijmegen, Netherlands, NL-6500 HB|
|University Hospital - Rotterdam Dijkzigt|
|Rotterdam, Netherlands, 3000 CA|
|Erasmus Medical Center|
|Rotterdam, Netherlands, 3075 EA|
|Academisch Ziekenhuis Utrecht|
|Utrecht, Netherlands, 3584 CX|
|Instituto de Enfermedades Neoplasicas|
|Lima, Peru, 34|
|Medical University of Gdansk|
|Gdansk, Poland, 80-211|
|Regional Lung Diseases Hospital|
|Poznan, Poland, 60 569|
|Basel, Switzerland, CH-4031|
|Bern, Switzerland, CH-3010|
|Kantonsspital - St. Gallen|
|St. Gallen, Switzerland, CH-9007|
|Nottingham City Hospital NHS Trust|
|Nottingham, England, United Kingdom, NG5 1PB|
|Weston Park Hospital|
|Sheffield, England, United Kingdom, S1O 2SJ|
|Western General Hospital|
|Edinburgh, Scotland, United Kingdom, EH4 2XU|
|Study Chair:||Jan P. Van Meerbeeck, MD, PhD||University Medical Center Rotterdam at Erasmus Medical Center|