Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Closed	Not specified	Other	BTS-MESO-1 MRC-BTS-MESO-1, EU-20134, NCT00030459

Objectives

1. 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.
2. Determine the quality of life of patients treated with these regimens.

Entry 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

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for mesothelioma

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics

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

Expected Enrollment

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

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.

Trial Contact Information

Trial Lead Organizations

British Thoracic Society

Martin Muers, MD, Protocol chair		Ph: 44-113-392-5299

Medical Research Council Clinical Trials Unit

David J. Girling, MD, Protocol chair		Ph: 44-20-7670-4734

Registry Information
Official Title		Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma
Trial Start Date		2000-11-22
Registered in ClinicalTrials.gov		NCT00030459
Date Submitted to PDQ		2001-12-04
Information Last Verified		2003-05-08

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