Spots Global Cancer Trial Database for Azacitidine and Entinostat in Treating Patients With Stage I Non-Small Cell Lung Cancer That Has Been Removed By Surgery
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Trial Identification
Brief Title: Azacitidine and Entinostat in Treating Patients With Stage I Non-Small Cell Lung Cancer That Has Been Removed By Surgery
Official Title: Randomized Phase II Trial of Adjuvant Combined Epigenetic Therapy With 5-Azacitidine and Entinostat in Resected Stage I Non-small Cell Lung Cancer Versus Standard Care
Study ID: NCT01207726
Study Description
Brief Summary: This study combines the deoxyribonucleic acid (DNA) methyltransferase inhibitor, 5-azacitidine (5-AZA), with an orally bioavailable histone deacetylase inhibitor, entinostat (SNDX-275), for the adjuvant treatment of patients with resected stage I non-small cell lung cancer (NCSLC).
Detailed Description: PRIMARY OBJECTIVES: I. To assess the effect of 5-azacitidine and entinostat on the hazard of 3 year progression-free survival in patients with resected stage I non-small cell lung cancer. SECONDARY OBJECTIVES: I. To assess the safety, tolerability and toxicity of entinostat and 5-azacitidine in patients with resected stage I non-small cell lung cancer. II. To explore the effect of entinostat and 5-azacitidine on median disease-free and overall survival in patients with resected stage I non-small cell lung cancer. III. To assess the pharmacodynamic effects of 5-azacitidine and entinostat on DNA methylation and gene re-expression in patients with resected stage I NSCLC through analysis of sputum. IV. To estimate the effect of entinostat and 5-azacitidine on progression free survival comparing patients with N2 lymph nodes categorized as methylated pre-treatment with those who are categorized as unmethylated. V. To establish factors that predict clinical outcome in patients treated with combination epigenetic therapy by performing genome-wide analyses on pre-treatment tumor DNA. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive azacitidine subcutaneously (SC) on days 1-5 and 8-10 and entinostat orally (PO) once daily (QD) on days 3 and 10. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive standard of care. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
USC / Norris Comprehensive Cancer Center, Los Angeles, California, United States
Moffitt Cancer Center, Tampa, Florida, United States
Anne Arundel Medical Center, Annapolis, Maryland, United States
Greater Baltimore Medical Center, Baltimore, Maryland, United States
Johns Hopkins Bayview Medical Center, Baltimore, Maryland, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital, Baltimore, Maryland, United States
University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania, United States
Vanderbilt-Ingram Cancer Center, Nashville, Tennessee, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
Contact Details
Name: Charles Rudin
Affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Role: PRINCIPAL_INVESTIGATOR
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