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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-04

Study Completion Date

2017-05-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metastatic Malignant Neoplasm in the Lung Stage IIIB Non-Small Cell Lung Cancer Stage IV Adult Soft Tissue Sarcoma Stage IV Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (cisplatin)

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.

Group Type EXPERIMENTAL

Cisplatin

Intervention Type DRUG

Given intra-arterially via isolated lung suffusion

Pharmacological Study

Intervention Type OTHER

Correlative studies

Interventions

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Cisplatin

Given intra-arterially via isolated lung suffusion

Intervention Type DRUG

Pharmacological Study

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Abiplatin Blastolem Briplatin CDDP Cis-diammine-dichloroplatinum Cis-diamminedichloridoplatinum Cis-diamminedichloro Platinum (II) Cis-diamminedichloroplatinum Cis-dichloroammine Platinum (II) Cis-platinous Diamine Dichloride Cis-platinum Cis-platinum II Cis-platinum II Diamine Dichloride Cismaplat Cisplatina Cisplatinum Cisplatyl Citoplatino Citosin Cysplatyna DDP Lederplatin Metaplatin Neoplatin Peyrone's Chloride Peyrone's Salt Placis Plastistil Platamine Platiblastin Platiblastin-S Platinex Platinol Platinol- AQ Platinol-AQ Platinol-AQ VHA Plus Platinoxan Platinum Platinum Diamminodichloride Platiran Platistin Platosin

Eligibility Criteria

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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

Exclusion Criteria

* 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)

* 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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No