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

NCT00004920 | Completed Phase 3

• 1 other identifier: EORTC-08983
• Study Type: interventional
• Target: 256
• Locations: 11 countries
• Sites: 26

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.

Conditions

Malignant Mesothelioma

Keywords

localized malignant mesothelioma; advanced malignant mesothelioma; recurrent malignant mesothelioma

Interventions

cisplatin DRUG

raltitrexed DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (26)

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Cancer Care Ontario-Hamilton Regional Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

Cancer Care Ontario-London Regional Cancer Centre

London, Ontario, N6A 4L6, Canada

Location

Trillium Health Centre

Mississauga, Ontario, L5B 1B8, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

McGill University

Montreal, Quebec, H2W 1S6, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

National Cancer Institute of Egypt

Cairo, Egypt

Location

Assistance Publique Hopitaux de Marseille Hopitaux Sud

Marseille, 13274, France

Location

Hopital de la Conception

Marseille, 13385, France

Location

Hopital Charles Nicolle

Rouen, 76031, France

Location

Thoraxklinik Rohrbach

Heidelberg, D-69126, Germany

Location

Istituto Nazionale per la Ricerca sul Cancro

Genoa (Genova), 16132, Italy

Location

University Medical Center Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

University Hospital - Rotterdam Dijkzigt

Rotterdam, 3000 CA, Netherlands

Location

Erasmus Medical Center

Rotterdam, 3075 EA, Netherlands

Location

Academisch Ziekenhuis Utrecht

Utrecht, 3584 CX, Netherlands

Location

Instituto de Enfermedades Neoplasicas

Lima, 34, Peru

Location

Medical University of Gdansk

Gdansk, 80-211, Poland

Location

Regional Lung Diseases Hospital

Poznan, 60 569, Poland

Location

University Hospital

Basel, CH-4031, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Related Publications (5)

• 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. doi: 10.1200/JCO.2005.05.1359.

  PMID: 16809726 BACKGROUND

• 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. doi: 10.1200/JCO.2007.12.5294.

  PMID: 18089874 RESULT

• 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. doi: 10.1200/JCO.2005.03.3027. Epub 2006 Jan 30.

  PMID: 16446322 RESULT

• 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. doi: 10.1200/JCO.20005.14.589.

  PMID: 16192580 RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Mesothelioma, Malignant

Interventions

Cisplatin; raltitrexed

Condition Hierarchy (Ancestors)

Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Jan P. Van Meerbeeck, MD, PhD

  University Medical Center Rotterdam at Erasmus Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2000
• First Posted: January 27, 2003
• Study Start: November 1, 1999
• Primary Completion: January 1, 2003
• Last Updated: July 18, 2012

Record last verified: 2012-07

Locations

BE (1); CA (6); PL (2); PE (1); CH (3); IT (1); EG (1); DE (1); GB (3); NL (4); FR (3)