Combination Chemotherapy Before Surgery in Treating Patients With Mesothelioma of the Lung

OBJECTIVES:

• Determine the proportion of patients with potentially resectable mesothelioma of the pleura remaining operable after treatment with neoadjuvant cisplatin and gemcitabine.
• Determine the response rate and overall survival of patients treated with this regimen.
• Determine the tolerability of this regimen in these patients.
• Determine the number of postoperative hospitalization days and occurrence and duration of surgical complications in patients treated with this regimen.
• Determine the quality of life of patients treated with this regimen.
• Compare the proportion of patients who report psychological distress at 3 months after surgery vs at study registration.

OUTLINE: Patients receive cisplatin IV on day 1 and gemcitabine IV on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses. Within 6 weeks after completion of chemotherapy, patients undergo restaging by CT scan followed by surgical resection.

Quality of life is assessed at baseline, day 1 of course 3, within 4 weeks after surgery, and then at 3 and 6 months.

Patients are followed every 3 months for 1 year and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 61 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically and clinically confirmed pleural mesothelioma

• Stages T1-3, N0-2, M0 by CT scan of the chest

• Mediastinoscopy required for staging of mediastinal lymph nodes
• Considered completely resectable

PATIENT CHARACTERISTICS:

Age:

• Over 18

Performance status:

• WHO 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• No severe liver disease

Renal:

• Creatinine no greater than 1.7 mg/dL

Cardiac:

• Adequate cardiac function
• No cardiac disease that would preclude forced hydration or surgery

Pulmonary:

• Predicted postoperative FEV_1 greater than 1 by spirometry

Other:

• No contraindication to surgery
• No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
• No uncontrolled infection
• No uncontrolled diabetes
• No neurologic or psychiatric disorders that would preclude study compliance
• No other serious illnesses that would preclude study participation
• No other circumstances that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• No prior pleurectomy or lung resection except for diagnostic purposes