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

PRIMARY OBJECTIVES:

I. To determine the maximum tolerated dose and dose-limiting toxicities of cisplatin when
delivered selectively by isolated lung suffusion to patients with any biopsy or cytologically
proven resectable or unresectable primary or secondary malignancy in the lung.

SECONDARY OBJECTIVES:

I. To assess lung tissue levels of cisplatin after isolated lung suffusion as a function of
the dose delivered.

II. To evaluate systemic and pulmonary artery concentrations of cisplatin during isolated
lung suffusion.

OUTLINE: This is a dose-escalation study.

Patients receive cisplatin intra-arterially via isolated lung suffusion over 2 hours.
Beginning approximately 2 weeks later (6-8 weeks if indicated for patients with sarcoma
undergoing surgery after cisplatin), patients receive standard chemotherapy regimen.

After completion of study treatment, patients are followed up for at least 90 days.

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)