RATIONALE: Active symptom control may decrease chest pain, breathlessness, sweating, and general discomfort in patients with malignant pleural mesothelioma. It is not yet known if active symptom control is more effective with or without chemotherapy.

PURPOSE: This randomized phase III trial is studying active symptom control and chemotherapy to see how well they work compared to active symptom control alone in treating patients with malignant pleural mesothelioma.

Condition	Treatment or Intervention	Phase
epithelial mesothelioma localized malignant mesothelioma advanced malignant mesothelioma	Drug: cisplatin  Drug: mitomycin  Drug: vincristine  Drug: vinorelbine  Procedure: chemotherapy  Procedure: pain therapy  Procedure: psychosocial assessment/care  Procedure: quality-of-life assessment  Procedure: supportive care/therapy	Phase III

Further Study Details: 

OBJECTIVES: Primary

• Compare the overall survival of patients with malignant pleural mesothelioma treated with active symptom control (ASC) alone vs ASC and mitomycin, vinblastine, and cisplatin vs ASC and vinorelbine.

Secondary

• Compare the toxic effects of these regimens in these patients.
• Compare symptom palliation (chest pain, breathlessness, malaise, and sweating attacks) in patients treated with these regimens.
• Compare the performance status of patients treated with these regimens.
• Compare analgesic usage in patients treated with these regimens.
• Compare the tumor response and progression-free survival of patients treated with these regimens.
• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 3 treatment arms.

• Arm I: Patients receive active symptom control (ASC) through regular visits at a specialist clinic. ASC may include steroids, analgesics, appetite stimulants, bronchodilators, and/or palliative radiotherapy, when required.
• Arm II: Patients receive ASC and chemotherapy comprising mitomycin IV, vincristine IV, and cisplatin IV on day 1. Chemotherapy repeats every 21 days for a total of 4 courses.
• Arm III: Patients receive ASC and vinorelbine IV over 5 minutes weekly for 6 weeks. Vinorelbine repeats every 55 days for a total of 2 courses. Quality of life is assessed at baseline, every 3 weeks for 21 weeks, and then every 8 weeks thereafter.

Patients are followed at 15, 18, and 21 weeks, and then every 8 weeks thereafter.

PROJECTED ACCRUAL: A total of 840 patients (280 per treatment arm) will be accrued for this study within 4 years.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically and immunohistochemically confirmed malignant pleural mesothelioma
• Epithelial and other histological types are allowed
• No more than 3 months since diagnosis
• Symptomatic pleural effusion must have been treated and brought under control by drainage, pleurodesis, or pleurectomy
• Prior surgical resection of mesothelioma allowed provided 2 CT scans at least 6 weeks apart show stable or progressive disease

PATIENT CHARACTERISTICS: Age

• 18 and over

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• WBC > 3,000/mm^3
• Absolute neutrophil count > 1,500/mm^3
• Platelet count > 100,000/mm^3

Hepatic

• Not specified

Renal

• Creatinine clearance > 50 mL/min

Pulmonary

• See Disease Characteristics

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• Considered medically fit to receive chemotherapy
• No other disease or prior malignancy likely to interfere with protocol treatments or comparisons
• No clinical evidence of infection

PRIOR CONCURRENT THERAPY: Biologic therapy

• Not specified

Chemotherapy

• No prior chemotherapy for mesothelioma

Endocrine therapy

• Not specified

Radiotherapy

• Prior local radiotherapy to a wound site after exploratory thoracotomy allowed

Surgery

• See Disease Characteristics
• See Radiotherapy

United Kingdom, England
      Leeds General Infirmary at Leeds Teaching Hospital NHS Trust, Leeds,  England,  LS1 3EX,  United Kingdom; Recruiting
      Royal Marsden NHS Foundation Trust - Surrey, Sutton,  England,  SM2 5PT,  United Kingdom; Recruiting
      Saint Bartholomew's Hospital, London,  England,  EC1A 7BE,  United Kingdom; Recruiting

Study chairs or principal investigators

Martin F. Muers, MD,  Principal Investigator,  Leeds General Infirmary at Leeds Teaching Hospital NHS Trust   

Study ID Numbers:  CDR0000347461; BTS-MRC-MS01; ISRCTN-54469112; EU-20349; NCT00075699
Record last reviewed:  December 2003
Last Updated:  April 5, 2005
Record first received:  January 9, 2004
ClinicalTrials.gov Identifier:  NCT00075699
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08