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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma

Conditions
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Malignant Mesothelioma

Intervention / Treatment
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* Drug: cisplatin
* Drug: mitomycin C
* Drug: vinblastine sulfate
* Drug: vinorelbine tartrate


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cisplatin|nan|
|Drug: mitomycin C|nan|
|Drug: vinblastine sulfate|nan|
|Drug: vinorelbine tartrate|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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localized malignant mesothelioma, advanced malignant mesothelioma, recurrent malignant mesothelioma