Brief Title
Palliative Therapy With or Without Chemotherapy in Treating Patients With Malignant Mesothelioma
Official Title
Randomized Feasibility Study Of Active Symptom Control With Or Without Chemotherapy In The Treatment Of Patients With Mesothelioma
Brief Summary
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
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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Malignant Mesothelioma
Intervention
cisplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Start Date
November 2000
Eligibility 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
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Martin F. Muers, MD, ,
Location Countries
United Kingdom
Location Countries
United Kingdom
Administrative Informations
NCT ID
NCT00030459
Organization ID
BTS-MESO-1
Secondary IDs
CDR0000069167
Study Sponsor
British Thoracic Society
Collaborators
Medical Research Council
Study Sponsor
Martin F. Muers, MD, Study Chair, Leeds General Infirmary
Verification Date
May 2003