Mesothelioma Related Clinical Trials:
Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma

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Status: Active
Sponsors and Collaborators: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00004920

Condition: Malignant Mesothelioma
Intervention: Drug: cisplatin; Drug: raltitrexed; Procedure: chemotherapy

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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.

Study Type: Interventional
Study Design: Treatment, Randomized, Active Control
Official Title: Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: November 1999

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.

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Eligibility:

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed malignant pleural mesothelioma
  • No CNS metastases

PATIENT CHARACTERISTICS:

Age:

  • Over 18

Performance status:

  • ZUBROD, ECOG, WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • 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

Hepatic:

  • 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)

Renal:

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

Cardiovascular:

  • Not specified

Pulmonary:

  • Not specified

Other:

  • 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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy before first disease progression

Chemotherapy:

  • 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

Radiotherapy:

  • 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

Surgery:

  • Prior surgery allowed if followed by disease progression

Other:

  • At least 1 month since prior investigational drugs

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Contacts and Locations:

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004920
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

Sponsors and Collaborators
European Organization for Research and Treatment of Cancer

Investigators
Study Chair: Jan P. Van Meerbeeck, MD, PhD University Medical Center Rotterdam at Erasmus Medical Center

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Additional Information:

Publications of Results:
Bottomley A, Coens C, Efficace F, Gaafar R, Manegold C, Burgers S, Vincent M, Legrand C, van Meerbeeck JP; EORTC-NCIC. Symptoms and patient-reported well-being: do they predict survival in malignant pleural mesothelioma? A prognostic factor analysis of EORTC-NCIC 08983: randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma. J Clin Oncol. 2007 Dec 20;25(36):5770-6.
Bottomley A, Gaafar R, Manegold C, Burgers S, Coens C, Legrand C, Vincent M, Giaccone G, Van Meerbeeck J; EORTC Lung-Cancer Group; National Cancer Institute, Canada. Short-term treatment-related symptoms and quality of life: results from an international randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an EORTC Lung-Cancer Group and National Cancer Institute, Canada, Intergroup Study. J Clin Oncol. 2006 Mar 20;24(9):1435-42. Epub 2006 Jan 30. Erratum in: J Clin Oncol. 2006 Jun 1;24(16):2601. Gaafa, Rabab [corrected to Gaafar, Rahab].
van Meerbeeck JP, Gaafar R, Manegold C, Van Klaveren RJ, Van Marck EA, Vincent M, Legrand C, Bottomley A, Debruyne C, Giaccone G; European Organisation for Research and Treatment of Cancer Lung Cancer Group; National Cancer Institute of Canada. Randomized phase III study of cisplatin with or without raltitrexed in patients with malignant pleural mesothelioma: an intergroup study of the European Organisation for Research and Treatment of Cancer Lung Cancer Group and the National Cancer Institute of Canada. J Clin Oncol. 2005 Oct 1;23(28):6881-9.
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.

Other Publications:
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.

Study ID Numbers: CDR0000067603, EORTC-08983
First Received: March 7, 2000
Last Updated: December 21, 2007
ClinicalTrials.gov Identifier: NCT00004920
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma

Study placed in the following topic categories:
Folic Acid
Cisplatin
Mesothelioma
Raltitrexed
Adenoma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Mesothelioma
Antimetabolites
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Neoplasms, Mesothelial
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Folic Acid Antagonists
Pharmacologic Actions
Neoplasms
Radiation-Sensitizing Agents
Therapeutic Uses

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