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| Sponsor: | European Organization for Research and Treatment of Cancer |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004920 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Malignant Mesothelioma |
Drug: cisplatin Drug: raltitrexed |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Active Control |
| Official Title: | Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma |
| Study Start Date: | November 1999 |
OBJECTIVES:
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.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Hide Study Locations| Belgium | |
| U.Z. Gasthuisberg | |
| Leuven, Belgium, B-3000 | |
| Canada, Ontario | |
| Cancer Care Ontario-Hamilton Regional Cancer Centre | |
| Hamilton, Ontario, Canada, L8V 5C2 | |
| Cancer Care Ontario-London Regional Cancer Centre | |
| London, Ontario, Canada, N6A 4L6 | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Trillium Health Centre | |
| Mississauga, Ontario, Canada, L5B 1B8 | |
| Canada, Quebec | |
| McGill University | |
| Montreal, Quebec, Canada, H2W 1S6 | |
| Canada, Saskatchewan | |
| Allan Blair Cancer Centre | |
| Regina, Saskatchewan, Canada, S4T 7T1 | |
| Egypt | |
| National Cancer Institute of Egypt | |
| Cairo, Egypt | |
| France | |
| Assistance Publique Hopitaux de Marseille Hopitaux Sud | |
| Marseille, France, 13274 | |
| Hopital Charles Nicolle | |
| Rouen, France, 76031 | |
| Hopital de la Conception | |
| Marseille, France, 13385 | |
| Germany | |
| Thoraxklinik Rohrbach | |
| Heidelberg, Germany, D-69126 | |
| Italy | |
| Istituto Nazionale per la Ricerca sul Cancro | |
| Genoa (Genova), Italy, 16132 | |
| Netherlands | |
| Academisch Ziekenhuis Utrecht | |
| Utrecht, Netherlands, 3584 CX | |
| Erasmus Medical Center | |
| Rotterdam, Netherlands, 3075 EA | |
| University Hospital - Rotterdam Dijkzigt | |
| Rotterdam, Netherlands, 3000 CA | |
| University Medical Center Nijmegen | |
| Nijmegen, Netherlands, NL-6500 HB | |
| Peru | |
| Instituto de Enfermedades Neoplasicas | |
| Lima, Peru, 34 | |
| Poland | |
| Medical University of Gdansk | |
| Gdansk, Poland, 80-211 | |
| Regional Lung Diseases Hospital | |
| Poznan, Poland, 60 569 | |
| Switzerland | |
| Inselspital, Bern | |
| Bern, Switzerland, CH-3010 | |
| Kantonsspital - St. Gallen | |
| St. Gallen, Switzerland, CH-9007 | |
| University Hospital | |
| Basel, Switzerland, CH-4031 | |
| United Kingdom, England | |
| Nottingham City Hospital NHS Trust | |
| Nottingham, England, United Kingdom, NG5 1PB | |
| Weston Park Hospital | |
| Sheffield, England, United Kingdom, S1O 2SJ | |
| United Kingdom, Scotland | |
| 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 |
More Information
| Study ID Numbers: | CDR0000067603, EORTC-08983 |
| Study First Received: | March 7, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00004920 History of Changes |
| Health Authority: | United States: Federal Government |
|
localized malignant mesothelioma advanced malignant mesothelioma recurrent malignant mesothelioma |
|
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Folic Acid Antagonists |
Pharmacologic Actions Neoplasms Cisplatin Radiation-Sensitizing Agents Therapeutic Uses Mesothelioma Raltitrexed Adenoma Neoplasms, Glandular and Epithelial |