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Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura

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ClinicalTrials.gov Identifier: NCT00004920
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

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.

Condition or disease Intervention/treatment Phase
Malignant Mesothelioma Drug: cisplatin Drug: raltitrexed Phase 3

Detailed Description:


  • 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 256 participants
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma
Drug Information available for: Cisplatin
U.S. FDA Resources

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed malignant pleural mesothelioma
  • No CNS metastases



  • Over 18

Performance status:


Life expectancy:

  • Not specified


  • 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


  • 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)


  • Creatinine less than 1.69 mg/dL
  • Creatinine clearance at least 65 mL/min


  • Not specified


  • Not specified


  • 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


Biologic therapy:

  • No concurrent immunotherapy before first disease progression


  • 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


  • 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


  • Prior surgery allowed if followed by disease progression


  • At least 1 month since prior investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004920

  Hide Study Locations
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
Trillium Health Centre
Mississauga, Ontario, Canada, L5B 1B8
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
McGill University
Montreal, Quebec, Canada, H2W 1S6
Canada, Saskatchewan
Allan Blair Cancer Centre
Regina, Saskatchewan, Canada, S4T 7T1
National Cancer Institute of Egypt
Cairo, Egypt
Assistance Publique Hopitaux de Marseille Hopitaux Sud
Marseille, France, 13274
Hopital de la Conception
Marseille, France, 13385
Hopital Charles Nicolle
Rouen, France, 76031
Thoraxklinik Rohrbach
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
University Hospital
Basel, Switzerland, CH-4031
Inselspital, Bern
Bern, Switzerland, CH-3010
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
United Kingdom
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
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
Study Chair: Jan P. Van Meerbeeck, MD, PhD University Medical Center Rotterdam at Erasmus Medical Center

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.

Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier: NCT00004920     History of Changes
Other Study ID Numbers: EORTC-08983
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Enzyme Inhibitors