NCT01281124

Azacitidine in Treating Patients With Previously Treated Advanced Non-Small Cell Lung Cancer

Pilot Phase II Study of 5-Azacytidine in Previously Treated Patients With Advanced NSCLC

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II clinical trial is studying how well azacitidine works in treating patients with previously treated advanced non-small cell lung cancer. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description

PRIMARY OBJECTIVES: I. To determine the ability of 5-azacytidine to cause DNA hypomethylation and re-expression of silenced tumor suppressor genes when stratified for high or low expression of mir29a, b, and c. SECONDARY OBJECTIVES: I. To compare the molecular studies (mir29 expression and tumor suppressor gene methylation) between archival tissue, fresh biopsy pre-treatment samples, and post-treatment fresh samples. II. To determine the overall response rate by CT (RECIST 1.1 criteria) and PET (EORTC PET response criteria), PFS, and OS of patients treated with azacytidine in the second- or third-line setting. III. To correlate the blood microRNA profiles (and changes in microRNA profiles) with response to azacytidine. OUTLINE: Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo tissue and blood sample collection at baseline and periodically during study treatment for correlative studies. After completion of study treatment, patients are followed up for 12 weeks.

Conditions

• Recurrent Lung Non-Small Cell Carcinoma
• Stage IV Lung Non-Small Cell Cancer AJCC v7

Interventions

Type	Name	Description
DRUG	Azacitidine	Given subcutaneously
OTHER	Diagnostic Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies

Timeline

• Start date: 2011-01-12
• Primary completion: 2011-04-15
• Completion: 2012-09-12
• First posted: 2011-01-21
• Last updated: 2019-09-24
• Results posted: 2013-09-13

Locations

1 site across 1 country: United States