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Sponsors and Collaborators: |
British Thoracic Society Medical Research Council |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00030459 |
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 | Intervention | Phase |
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Malignant Mesothelioma |
Drug: cisplatin Drug: mitomycin C Drug: vinblastine Drug: vinorelbine ditartrate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
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 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of three treatment arms.
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Immunohistochemically or cytologically confirmed malignant mesothelioma
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
United Kingdom | |
Dorothy House Foundation | |
Bradford-Onavon, United Kingdom, BA15 2LE | |
St. Peters Hospital | |
Chertsey Surrey, United Kingdom, KT 16 OPZ | |
United Kingdom, England | |
Leeds Teaching Hospital Trust | |
Leeds, England, United Kingdom, LS1 3EX | |
Medical Research Council Clinical Trials Unit | |
London, England, United Kingdom, NW1 2DA | |
Princess Royal Hospital | |
Hull, England, United Kingdom, HU8 9HE | |
Royal Marsden Hospital | |
Sutton, England, United Kingdom, SM2 5PT | |
Saint Bartholomew's Hospital | |
London, England, United Kingdom, EC1A 7BE | |
United Kingdom, Scotland | |
Aberdeen Royal Infirmary | |
Aberdeen, Scotland, United Kingdom, AB25 2ZN | |
Stobhill General Hospital | |
Glasgow, Scotland, United Kingdom, G21 3UW |
Study Chair: | Martin F. Muers, MD | Leeds General Infirmary |
Study Chair: | David J. Girling, MD | Medical Research Council |
Study ID Numbers: | CDR0000069167, BTS-MESO-1, MRC-BTS-MESO-1, EU-20134 |
Study First Received: | February 14, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00030459 |
Health Authority: | United States: Federal Government |
localized malignant mesothelioma advanced malignant mesothelioma recurrent malignant mesothelioma |
Vinorelbine Cisplatin Mitomycin Mesothelioma Vinblastine |
Mitomycins Adenoma Recurrence Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Mitosis Modulators Enzyme Inhibitors Antimitotic Agents Antibiotics, Antineoplastic |
Pharmacologic Actions Neoplasms Therapeutic Uses Tubulin Modulators Alkylating Agents Antineoplastic Agents, Phytogenic Nucleic Acid Synthesis Inhibitors |