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
Purpose: Evaluate a new treatment utilizing epigenetic therapy through methyltransferase inhibitors and histone deactylase inhibitors to address methylation in the treatment of early stage lung cancer. Compare the use of a combination of drugs after surgery vs. surgery with standard care in patients diagnosed with Stage 1 Non-Small Cell Lung Cancer (NSCLC). The primary objective is to evaluate progression-free survival benefit, and secondarily to evaluate safety, tolerability and toxicity of the treatment, as well as establish factors that predict outcome.
Eligibility: Patients must be post complete resection of pathologically proven NSCLC (stage 1A-1B), between 4 -8 weeks out from surgery, greater than 18 years old, with acceptable lab values and performance score. Patients will be excluded if greater than 8weeks post surgery, received chemotherapy or radiation for current diagnosis of lung cancer, had less than a complete lobe resected or without mediastinal lymph node specimens from surgery, have uncontrolled intercurrent illness or are receiving any other investigational agents.
Study Overview/Treatment: This is a Phase II study with a 28 day cycle for up to 6 cycles total. Eligible patients will be randomized to treatment or standard care. All patients will need to collect sputum and blood specimens, have physical examinations and radiological imaging. Those randomized to treatment will receive subcutaneous injections of 5 Azacitidine in the participating sites outpatient setting on days 1-5 and 8-10, and an oral agent, Entinostat, on days 3 and 10 of each cycle for up to 6 cycles.
05/22/2013 04:02 AM