Active Symptom Control With or Without Chemotherapy in Treating Patients With Malignant Pleural Mesothelioma

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical Research Council
• Treatments: Mitomycin; Mitomycins; Vincristine; Vinorelbine

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