Mesothelioma Related Clinical Trials:
Aggressive Multi-Modality Management of Malignant Pleural Mesothelioma

• Response to chemotherapy [ Designated as safety issue: No ]
  

• Tolerability and toxicity [ Designated as safety issue: Yes ]
  
• Relapse free and overall survival [ Designated as safety issue: No ]
  
• Operability and surgical success [ Designated as safety issue: No ]
  
• Quality of life [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Assess the response to induction combination chemotherapy comprising methotrexate, vinorelbine ditartrate, and cisplatin in patients with previously untreated malignant pleural mesothelioma.

Secondary

• Assess the tolerability and toxicity of this regimen in these patients.
• Determine relapse-free and overall survival of patients treated with induction combination chemotherapy with or without surgery and hemithoracic radiation.
• Assess the impact of induction combination chemotherapy on operability and surgical success.
• Evaluate the impact of these treatment regimens on quality of life.

OUTLINE:

• Induction chemotherapy: Patients receive MVP chemotherapy comprising cisplatin IV over 30-60 minutes on day 1 and vinorelbine ditartrate IV over 5-10 minutes and methotrexate IV over 5-30 minutes on days 8, 15, and 22. Treatment repeats every 28 days for 2 courses. Patients with unresectable disease may receive up to 2 additional courses of induction chemotherapy. Patients requiring palliative radiotherapy or who have progressive disease are removed from the study. Patients with resectable disease or sarcomatoid histology and T1-3, N1-2 disease with a complete or partial response to induction chemotherapy proceed to surgery.
• Surgery: Patients with extensive disease undergo palliative debulking pleurectomy and decortication and then are taken off study. All other patients undergo a thoracotomy with an extrapleural pneumonectomy and then proceed to chemoradiotherapy.
• Chemoradiotherapy: Beginning 6-10 weeks after surgery, patients undergo 3-dimensional conformal or intensity-modulated radiotherapy once daily, 5 days a week, for 6 weeks. Patients also receive cisplatin IV over 30-60 minutes on days 1 and 22. Patients with responding disease proceed to adjuvant chemotherapy.
• Adjuvant chemotherapy: Patients receive 2 additional courses of MVP chemotherapy as above.

Quality of life is assessed at baseline, after each course of induction chemotherapy, before surgery, and then every 3 months thereafter.

After completion of study therapy, patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed malignant pleural mesothelioma

  • Amenable to aggressive surgical resection, if deemed resectable

    • Patients with potentially resectable disease must have undergone mediastinoscopy to establish surgical stage

      • Resectable disease is defined as any of the following:

        • Epithelioid, mixed histology, or histology not otherwise specified with clinical stage I-III (T1-3, N0-2, M0) disease
        • Sarcomatoid histology with clinical stage I-III (T1-3, N0) disease
  • Intraperitoneal extension, contralateral thoracic extension, or distant metastases are eligible, but considered unresectable
    • Disease considered unresectable by any medical reason or if surgery was declined

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• WBC ≥ 3,000/mm³
• Platelet count > 100,000/mm³
• Creatinine ≤ 1.7 mg/dL
• Alkaline phosphatase < 2 times normal
• AST < 2 times normal
• Albumin > 3 g/dL
• Bilirubin < 2.0 mg/dL
• Patients must be available for and compliant with adequate long-term follow-up
• Not pregnant
• Negative pregnancy test
• Fertile patients must use effective contraception
• Patients with resectable disease must have adequate pulmonary function to undergo surgery and radiotherapy
• No other active malignancies

PRIOR CONCURRENT THERAPY:

• No prior surgical resection, radiation therapy, chemotherapy, or immunotherapy for this cancer

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