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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 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01014598
Study type Interventional
Source Roswell Park Cancer Institute
Contact
Status Completed
Phase Phase 1
Start date December 4, 2007
Completion date May 1, 2017
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