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

Primary Purpose

Malignant Mesothelioma

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
cisplatin
raltitrexed
Sponsored by
European Organisation for Research and Treatment of Cancer - EORTC
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Mesothelioma focused on measuring localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • U.Z. Gasthuisberg
  • Cancer Care Ontario-Hamilton Regional Cancer Centre
  • Cancer Care Ontario-London Regional Cancer Centre
  • Trillium Health Centre
  • Princess Margaret Hospital
  • McGill University
  • Allan Blair Cancer Centre
  • National Cancer Institute of Egypt
  • Assistance Publique Hopitaux de Marseille Hopitaux Sud
  • Hopital de la Conception
  • Hopital Charles Nicolle
  • Thoraxklinik Rohrbach
  • Istituto Nazionale per la Ricerca sul Cancro
  • University Medical Center Nijmegen
  • University Hospital - Rotterdam Dijkzigt
  • Erasmus Medical Center
  • Academisch Ziekenhuis Utrecht
  • Instituto de Enfermedades Neoplasicas
  • Medical University of Gdansk
  • Regional Lung Diseases Hospital
  • University Hospital
  • Inselspital, Bern
  • Kantonsspital - St. Gallen
  • Nottingham City Hospital NHS Trust
  • Weston Park Hospital
  • Western General Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 7, 2000
Last Updated
July 17, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
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1. Study Identification

Unique Protocol Identification Number
NCT00004920
Brief Title
Cisplatin With or Without Raltitrexed in Treating Patients With Malignant Mesothelioma of the Pleura
Official Title
Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 1999 (undefined)
Primary Completion Date
January 2003 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Mesothelioma
Keywords
localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
256 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Intervention Type
Drug
Intervention Name(s)
raltitrexed

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan P. Van Meerbeeck, MD, PhD
Organizational Affiliation
University Medical Center Rotterdam at Erasmus Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Cancer Care Ontario-Hamilton Regional Cancer Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 5C2
Country
Canada
Facility Name
Cancer Care Ontario-London Regional Cancer Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Trillium Health Centre
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 1B8
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1S6
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
National Cancer Institute of Egypt
City
Cairo
Country
Egypt
Facility Name
Assistance Publique Hopitaux de Marseille Hopitaux Sud
City
Marseille
ZIP/Postal Code
13274
Country
France
Facility Name
Hopital de la Conception
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Hopital Charles Nicolle
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Thoraxklinik Rohrbach
City
Heidelberg
ZIP/Postal Code
D-69126
Country
Germany
Facility Name
Istituto Nazionale per la Ricerca sul Cancro
City
Genoa (Genova)
ZIP/Postal Code
16132
Country
Italy
Facility Name
University Medical Center Nijmegen
City
Nijmegen
ZIP/Postal Code
NL-6500 HB
Country
Netherlands
Facility Name
University Hospital - Rotterdam Dijkzigt
City
Rotterdam
ZIP/Postal Code
3000 CA
Country
Netherlands
Facility Name
Erasmus Medical Center
City
Rotterdam
ZIP/Postal Code
3075 EA
Country
Netherlands
Facility Name
Academisch Ziekenhuis Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Instituto de Enfermedades Neoplasicas
City
Lima
ZIP/Postal Code
34
Country
Peru
Facility Name
Medical University of Gdansk
City
Gdansk
ZIP/Postal Code
80-211
Country
Poland
Facility Name
Regional Lung Diseases Hospital
City
Poznan
ZIP/Postal Code
60 569
Country
Poland
Facility Name
University Hospital
City
Basel
ZIP/Postal Code
CH-4031
Country
Switzerland
Facility Name
Inselspital, Bern
City
Bern
ZIP/Postal Code
CH-3010
Country
Switzerland
Facility Name
Kantonsspital - St. Gallen
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Weston Park Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S1O 2SJ
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
16809726
Citation
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.
Results Reference
background
PubMed Identifier
18089874
Citation
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.
Results Reference
result
PubMed Identifier
16446322
Citation
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. Erratum In: J Clin Oncol. 2006 Jun 1;24(16):2601. Gaafa, Rabab [corrected to Gaafar, Rahab].
Results Reference
result
PubMed Identifier
16192580
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result

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

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