Cisplatin in Treating Patients With Lung Cancer
This phase I trial is studying the side effects and best dose of cisplatin in treating patients with lung cancer. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving drugs directly into the arteries around the tumor may kill more tumor cells and cause less damage to normal tissue.
Recurrent Non-small Cell Lung Cancer
Stage IIIB Non-small Cell Lung Cancer
Stage IV Adult Soft Tissue Sarcoma
Stage IV Non-small Cell Lung Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Targeted Lung Chemotherapy in the Treatment of Metastatic Tumors|
- Frequency of patients experiencing dose limiting toxicities (DLT) as well as non-DLT, and to assess the reversibility of all toxicities from this approach [ Time Frame: Within 30 days of the procedure ] [ Designated as safety issue: Yes ]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.
- Lung, systemic, and pulmonary artery concentrations of cisplatin; and results from the split lung function test and pulmonary function test with diffusion capacity [ Time Frame: Before pulmonary artery (PA) release, at 15 minutes, and 1 hour ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2006|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Experimental: Treatment (chemotherapy)
Patients receive cisplatin IV via isolated lung suffusion over 2 hours. Beginning approximately 2 weeks later (6-8 weeks for patients with sarcoma undergoing surgery after cisplatin), patients receive standard care outpatient systemic infusions.
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.
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 intravenously (IV) via isolated lung suffusion over 2 hours. Beginning approximately 2 weeks later (6-8 weeks for patients with sarcoma undergoing surgery after cisplatin), patients receive standard care outpatient systemic infusions.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014598
|United States, New York|
|Roswell Park Cancer Institute||Recruiting|
|Buffalo, New York, United States, 14263|
|Contact: Roswell Park 877-275-7724 ASKRPCI@roswellpark.org|
|Principal Investigator: Todd L. Demmy|
|Principal Investigator:||Todd Demmy||Roswell Park Cancer Institute|