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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	Cisplatin	Given intra-arterially via isolated lung suffusion
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2007-12-04
• Primary completion: 2013-10-23
• Completion: 2017-05-01
• First posted: 2009-11-17
• Last updated: 2022-07-25

Locations

1 site across 1 country: United States