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Brief Title: Cisplatin in Treating Patients With Stage IIIB-IV Non-small Cell Lung Cancer or Lung Metastasis
Official Title: Phase I Study of Targeted Lung Chemotherapy in the Treatment of Metastatic Tumors
Study ID: NCT01014598
Brief 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Roswell Park Cancer Institute, Buffalo, New York, United States
Name: Chukwumere Nwogu
Affiliation: Roswell Park Cancer Institute
Role: PRINCIPAL_INVESTIGATOR