Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
NCT ID: NCT00030459
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
2000-11-30
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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cisplatin
mitomycin C
vinblastine sulfate
vinorelbine tartrate
Eligibility Criteria
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Inclusion Criteria
* 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
PATIENT CHARACTERISTICS:
Age:
* Not specified
Performance status:
* WHO 0-2
Life expectancy:
* Not specified
Hematopoietic:
* WBC greater than 3,000/mm3
* Neutrophil count greater than 1,500/mm3
* Platelet count greater than 100,000/mm3
Hepatic:
* Not specified
Renal:
* Not specified
Other:
* Considered medically fit to receive chemotherapy
* No other disease or prior malignancy that would preclude study
* No clinical evidence of infection
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No prior chemotherapy for mesothelioma
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* See Disease Characteristics
ALL
No
Sponsors
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Medical Research Council
OTHER_GOV
British Thoracic Society
OTHER
Principal Investigators
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Martin F. Muers, MD
Role: STUDY_CHAIR
Leeds General Infirmary
David J. Girling, MD
Role: STUDY_CHAIR
Medical Research Council
Locations
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Princess Royal Hospital
Hull, England, United Kingdom
Leeds Teaching Hospital Trust
Leeds, England, United Kingdom
Saint Bartholomew's Hospital
London, England, United Kingdom
Medical Research Council Clinical Trials Unit
London, England, United Kingdom
Royal Marsden Hospital
Sutton, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Stobhill General Hospital
Glasgow, Scotland, United Kingdom
Dorothy House Foundation
Bradford-Onavon, , United Kingdom
St. Peters Hospital
Chertsey Surrey, , United Kingdom
Countries
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Other Identifiers
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CDR0000069167
Identifier Type: REGISTRY
Identifier Source: secondary_id
MRC-BTS-MESO-1
Identifier Type: -
Identifier Source: secondary_id
EU-20134
Identifier Type: -
Identifier Source: secondary_id
BTS-MESO-1
Identifier Type: -
Identifier Source: org_study_id