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Mesothelioma Related Clinical Trials:
Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma
- General Info - Purpose - Eligibility - Contacts & Locations - Additional Information
Status: Active
Sponsors and Collaborators: British Thoracic Society, Medical Research Council
Information provided by: National Cancer Institute (NCI)
Government Identifier: NCT00030459
Condition: Malignant Mesothelioma
Intervention: Drug: cisplatin; Drug: mitomycin C; Drug: vinblastine; Drug: vinorelbine ditartrate; Procedure: chemotherapy
Purpose:
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.
| 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 |
Detailed Description:
OBJECTIVES:
- 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.
Eligibility:
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
DISEASE CHARACTERISTICS:
-
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
Contacts and Locations:
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030459Locations
| 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 | |||||
Sponsors and Collaborators
| British Thoracic Society |
| Medical Research Council |
Investigators
| Study Chair: | Martin F. Muers, MD | Leeds General Infirmary |
| Study Chair: | David J. Girling, MD | Medical Research Council |
Additional Information:
| Study ID Numbers: | CDR0000069167, BTS-MESO-1, MRC-BTS-MESO-1, EU-20134 |
| First Received: | February 14, 2002 |
| Last Updated: | February 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00030459 |
| Health Authority: | United States: Federal Government |
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