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

Roswell Park Comprehensive Cancer Center

Status and phase

Completed

Phase 1

Conditions

Stage IV Non-Small Cell Lung Cancer

Stage IV Adult Soft Tissue Sarcoma

Metastatic Malignant Neoplasm in the Lung

Stage IIIB Non-Small Cell Lung Cancer

Treatments

Other: Pharmacological Study

Drug: Cisplatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01014598

I 70005 (Other Identifier)

NCI-2009-01604 (Registry Identifier)

Details and patient eligibility

About

This phase I trial studies the side effects and best dose of cisplatin in treating patients with stage IIIB-IV non-small cell lung cancer or tumors that have spread from where they started to the lung (metastasis). Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving cisplatin directly into the arteries around the tumor may kill more tumor cells and cause less damage to normal tissue.

Full description

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.

Enrollment

11 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)