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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC
ClinicalTrials.gov Identifier:
NCT00004920
First received: March 7, 2000
Last updated: July 17, 2012
Last verified: July 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Phase III Study of Tomudex and Cisplatin Versus Cisplatin in Malignant Pleural Mesothelioma

Resource links provided by NLM:


Further study details as provided by European Organisation for Research and Treatment of Cancer - EORTC:

Enrollment: 256
Study Start Date: November 1999
Primary Completion Date: January 2003 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
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
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
Egypt
National Cancer Institute of Egypt
Cairo, Egypt
France
Hopital de la Conception
Marseille, France, 13385
Assistance Publique Hopitaux de Marseille Hopitaux Sud
Marseille, France, 13274
Hopital Charles Nicolle
Rouen, France, 76031
Germany
Thoraxklinik Rohrbach
Heidelberg, Germany, D-69126
Italy
Istituto Nazionale per la Ricerca sul Cancro
Genoa (Genova), Italy, 16132
Netherlands
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
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
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
Investigators
Study Chair: Jan P. Van Meerbeeck, MD, PhD University Medical Center Rotterdam at Erasmus Medical Center
  More Information

Additional Information:
Publications:
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, EORTC-08983
Study First Received: March 7, 2000
Last Updated: July 17, 2012
Health Authority: United States: Federal Government

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
Mesothelioma
Neoplasms, Mesothelial
Adenoma
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Cisplatin
Raltitrexed
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014