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

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.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

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

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