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

Stage IV Non-Small Cell Lung Cancer Clinical Trial

Official title:

Phase I Study of Targeted Lung Chemotherapy in the Treatment of Metastatic Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014598
• Other study ID #: I 70005
• Secondary ID: NCI-2009-01604I
• Status: Completed
• Phase: Phase 1
• Start date: December 4, 2007
• Est. completion date: May 1, 2017

Study information

• Verified date: July 2022
• Source: Roswell Park Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 1, 2017
• Est. primary completion date: October 23, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cisplatin
Given intra-arterially via isolated lung suffusion

Other:
• Pharmacological Study
Correlative studies

Locations

Country	Name	City	State
United States	Roswell Park Cancer Institute	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
Roswell Park Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicity assessed using CTCAE version 4.0		Within 7 days from lung infusion
Primary	Frequency of patients experiencing dose limiting toxicities (DLT) as well as non-DLT	DLT is defined according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. A grade 3 or above adverse event shall be considered a DLT in this study if attributed to the isolated lung suffusion cisplatin dose.	Within 30 days of the procedure
Primary	Reversibility of all toxicities from this approach.		Up to 90 days from the start of lung infusion therapy
Secondary	Lung, systemic, and pulmonary artery concentrations of cisplatin	Analysis of variance models with appropriate transformations of the variables, or nonparametric tests such as the Kruskal-Wallis test will be used as appropriate.	Before pulmonary artery release, at 15 minutes, and 1 hour
Secondary	Pulmonary function test with diffusion capacity	Will be summarized with respect to the percentage of cisplatin given directly to the lung. Analysis of variance models with appropriate transformations of the variables, or nonparametric tests such as the Kruskal-Wallis test will be used as appropriate.	Up to 30 days post-treatment
Secondary	Split lung function test	Will be summarized with respect to the percentage of cisplatin given directly to the lung. Analysis of variance models with appropriate transformations of the variables, or nonparametric tests such as the Kruskal-Wallis test will be used as appropriate.	Up to 30 days post-treatment