- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01014598
Cisplatin in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer or Lung Metastasis
Phase I Study of Targeted Lung Chemotherapy in the Treatment of Metastatic Tumors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
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Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
|
Correlative studies
Given intra-arterially via isolated lung suffusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute toxicity assessed using CTCAE version 4.0
Time Frame: Within 7 days from lung infusion
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Within 7 days from lung infusion
|
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Frequency of patients experiencing dose limiting toxicities (DLT) as well as non-DLT
Time Frame: Within 30 days of the procedure
|
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
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Reversibility of all toxicities from this approach.
Time Frame: Up to 90 days from the start of lung infusion therapy
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Up to 90 days from the start of lung infusion therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Lung, systemic, and pulmonary artery concentrations of cisplatin
Time Frame: Before pulmonary artery release, at 15 minutes, and 1 hour
|
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
|
Pulmonary function test with diffusion capacity
Time Frame: Up to 30 days post-treatment
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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.
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Up to 30 days post-treatment
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Split lung function test
Time Frame: Up to 30 days post-treatment
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Neoplasms
- Sarcoma
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Antineoplastic Agents
- Cisplatin
Other Study ID Numbers
- I 70005 (OTHER: Roswell Park Cancer Institute)
- NCI-2009-01604 (REGISTRY: CTRP (Clinical Trial Reporting Program))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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