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Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00030459
Recruitment Status : Unknown
Verified May 2003 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : August 7, 2013
Medical Research Council
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Palliative therapy may help patients with advanced cancer live more comfortably. It is not yet known if palliative therapy is more effective with or without chemotherapy in treating patients who have malignant mesothelioma.

PURPOSE: Randomized phase II trial to compare the effectiveness of palliative therapy with or without different chemotherapy regimens in treating patients who have malignant mesothelioma.

Condition or disease Intervention/treatment Phase
Malignant Mesothelioma Drug: cisplatin Drug: mitomycin C Drug: vinblastine sulfate Drug: vinorelbine tartrate Phase 2

Detailed Description:


  • Determine the feasibility of palliative therapy alone versus palliative therapy with mitomycin, vinblastine, and cisplatin versus palliative therapy with vinorelbine in patients with malignant mesothelioma.
  • Determine the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three treatment arms.

  • Arm I: Patients receive palliative therapy alone comprising non-chemotherapeutic therapy (e.g., radiotherapy, painkillers, steroids, relaxants, and special pain relief techniques).
  • Arm II: Patients receive palliative therapy as in arm I and chemotherapy comprising mitomycin IV (courses 1, 2, and 4 only), vinblastine IV, and cisplatin IV over 4 hours on day 1. Chemotherapy repeats every 21 days for a total of 4 courses.
  • Arm III: Patients receive palliative therapy as in arm I and chemotherapy comprising vinorelbine IV over 5 minutes once weekly on weeks 1-6 and 9-14.

Quality of life is assessed at baseline for all patients; at weeks 3, 6, 9, and 12 for arm I; at weeks 4, 7, 10, and 13 for arm II; at weeks 3, 6, 10, and 13 for arm III; at weeks 21 and 29, and then every 8 weeks thereafter for all patients.

Patients are followed every 8 weeks.

PROJECTED ACCRUAL: A total of 60 patients (20 per treatment arm) will be accrued for this study within 1 year.

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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma
Study Start Date : November 2000

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mesothelioma

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Immunohistochemically or cytologically confirmed malignant mesothelioma

    • Epithelial and other histological types
  • Symptomatic pleural effusion allowed if treated and controlled by drainage, pleurodesis, or pleurectomy
  • Prior surgical resection allowed if stable or progressive disease by 2 CT scan measurements at least 6 weeks apart



  • Not specified

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified


  • WBC greater than 3,000/mm3
  • Neutrophil count greater than 1,500/mm3
  • Platelet count greater than 100,000/mm3


  • Not specified


  • Not specified


  • Considered medically fit to receive chemotherapy
  • No other disease or prior malignancy that would preclude study
  • No clinical evidence of infection


Biologic therapy:

  • Not specified


  • No prior chemotherapy for mesothelioma

Endocrine therapy:

  • Not specified


  • Not specified


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00030459

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United Kingdom
Princess Royal Hospital
Hull, England, United Kingdom, HU8 9HE
Leeds Teaching Hospital Trust
Leeds, England, United Kingdom, LS1 3EX
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
Medical Research Council Clinical Trials Unit
London, England, United Kingdom, NW1 2DA
Royal Marsden Hospital
Sutton, England, United Kingdom, SM2 5PT
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Stobhill General Hospital
Glasgow, Scotland, United Kingdom, G21 3UW
Dorothy House Foundation
Bradford-Onavon, United Kingdom, BA15 2LE
St. Peters Hospital
Chertsey Surrey, United Kingdom, KT 16 OPZ
Sponsors and Collaborators
British Thoracic Society
Medical Research Council
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Study Chair: Martin F. Muers, MD Leeds General Infirmary
Study Chair: David J. Girling, MD Medical Research Council

Layout table for additonal information Identifier: NCT00030459    
Other Study ID Numbers: BTS-MESO-1
CDR0000069167 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: August 7, 2013
Last Verified: May 2003
Keywords provided by National Cancer Institute (NCI):
localized malignant mesothelioma
advanced malignant mesothelioma
recurrent malignant mesothelioma
Additional relevant MeSH terms:
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Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Alkylating Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors