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

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.

• Malignant Mesothelioma

• Drug: cisplatin
• Drug: mitomycin C
• Drug: vinblastine sulfate
• Drug: vinorelbine tartrate

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.

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