Cisplatin in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer or Lung Metastasis

This is an interventional treatment trial for Metastatic Malignant Neoplasm in the Lung Read More

Inclusion Criteria:

• Any biopsy or cytologically proven resectable or unresectable primary or secondary (metastatic) malignancy in the lung; this is defined as

  • Tumors whose only remaining residual deposits are confined to the lungs OR
  • Oligometastatic tumors with > 80% of measurable tumor volume in the target lung In both of the above situations, no clinical evidence of central nervous system (CNS) metastases can exist; oligometastatic disease is difficult to define but would, as a guideline, have only 1-4 loci of disease established in 1-2 organ systems outside the affected lung; exceptions to these guidelines can occur, particularly in cases where sites of metastatic disease are equivocal or so minute that it would not exceed 20% of tumor volume
• Unresectable stage IV non-small cell lung cancer (NSCLC)
• Unresectable stage IIIB NSCLC
• Resectable metastatic sarcoma to lung (thoracoscopically resectable)
• Other malignancies that meet the criteria
• Eastern Cooperative Oncology Group performance status 0-1
• No oxygen needs (oxygen use per standard established criteria for oxygen requirements)
• Modified Borg dyspnea scale < 5
• Six minute walk >= 50% of the expected distance; this will not be used as exclusion criteria if due to a reason other than respiratory per judgment of physician e.g., pain
• Ambulatory and resting oxygen (O2) saturation > 88%

• PPO (predicted post operative)* forced expiratory volume in one second (FEV1) >= 50% predicted

  • PPO values should be calculated for each patient

• PPO * diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% predicted

  • PPO values should be calculated for each patient

• PPO * vital capacity >= 50% predicted

  • PPO values should be calculated for each patient
• Granulocytes > 1,500 ul
• Platelets >= 100,000 ul
• Patients must sign a study-specific consent form prior to registration
• Tumor anatomy must allow the isolated lung suffusion in the judgment of the principal investigator (PI)

Exclusion Criteria:

• Uncontrolled intercurrent disease
• Prior chemotherapy for proven metastatic disease within 4 weeks
• Evidence of pulmonary toxicity from previous or ongoing chemotherapy
• Creatinine > 1.5 mg/dL
• Liver enzymes > 2 times upper normal
• Uncontrolled congestive heart failure (in judgment of the PI)
• Optional: ejection fraction < 40% for clinical evidence of insufficient cardiac reserve (multi gated acquisition scan [MUGA] or echocardiogram [ECHO] will be done only if indicated in the judgment of the PI)
• Myocardial infarction or angina within past 6 months
• Contraindications to anticoagulation
• Hydration intolerance (e.g., uncontrolled congestive heart failure [CHF])
• Human immunodeficiency virus positive (HIV+) on antiretroviral therapy
• Pregnant or lactating
• Diffuse pulmonary fibrosis involving over 25% of the total lung parenchyma
• Previous radiation for thorax
• Metastatic sarcoma to lung that is not able to have tumors resected thoracoscopically
• Prior lung removal in the affected lung (would have decreased lung volume)