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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01604 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 70005 | Other Identifier | Roswell Park Cancer Institute |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (cisplatin) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cisplatin | Drug | Given intra-arterially via isolated lung suffusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity assessed using CTCAE version 4.0 | Within 7 days from lung infusion | |
| 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 |
| Reversibility of all toxicities from this approach. | Up to 90 days from the start of lung infusion therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Pulmonary function test with diffusion capacity |
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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
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 * diffusing capacity of the lung for carbon monoxide (DLCO) >= 50% predicted
PPO * vital capacity >= 50% predicted
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:
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| Name | Affiliation | Role |
|---|---|---|
| Chukwumere Nwogu | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| Pharmacological Study | Other | Correlative studies |
|
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 |
| 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 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D002945 | Cisplatin |
| C044245 | 1,2-diaminocyclohexaneplatinum II citrate |
| D010984 | Platinum |
| ID | Term |
|---|---|
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |
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