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

This study is ongoing, but not recruiting participants.

Sponsored by: 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

MedlinePlus related topics:   Cancer    Mesothelioma   

Drug Information available for:   Cisplatin    ICI D1694   

U.S. FDA Resources

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.

  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
  Contacts and Locations

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

Show 26 study locations  Show 26 Study Locations

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    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

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:

Study ID Numbers:   CDR0000067603, EORTC-08983
First Received:   March 7, 2000
Last Updated:   July 23, 2008
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:
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

ClinicalTrials.gov processed this record on December 03, 2008




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