A Randomized Phase II Trial of Cytotoxic Chemotherapy with or without Epigenetic Priming in Patients with Advanced Non-Small Cell Lung Cancer.
Evaluate a new treatment utilizing epigenetic therapy through methyltransferase inhibitors and histone deactylase inhibitors in the treatment recurrent advanced non-small cell lung cancer. Compare the use of epigenetic therapy and standard treatment vs. standard treatment alone. To assess percentage of patients' response rate, and effect on patients' progression-free and overall survival.
Patients must have histologically or cytologically proven non-small cell lung cancer. Tumor tissue must be available from all patients prior to initiation of protocol therapy, either from original diagnostic biopsy, or biopsy performed prior to initiation of protocol therapy. Patients must have received one prior therapy, and no more than one prior therapy, greater than 18 years old, with acceptable lab values and performance score. Patients will be excluded if chemotherapy or radiotherapy is within 4 weeks prior to entering the study, have liver metastases that replace greater than 30% of the liver parenchyma, receiving any other investigational agents, or have uncontrolled intercurrent illness.
This is a randomized Phase II study of chemotherapy with or without epigenetic priming in patients with advanced non-small cell lung cancer. Eligible patients will be randomized to standard chemotherapy or standard chemotherapy preceded by epigenetic priming therapy. All patients will need to collect blood specimens, physical examinations, and radiological imaging. Optional biopsy for patients randomized to epigenetic priming arm. Those randomized to epigenetic priming will receive one of the following: (1) subcutaneous injections of Azaciditine on days 1-6 and days 8-10 and an oral agent Entinostat on days 3 and 10 of a 28 day cycle; or (2) oral Azacitidine on days 1-21 and an oral agent Entinostat on days 3 and 10 of a 28 day cycle. If randomized to standard treatment, chemotherapy will consist of the treating oncologist's choice from 4 single agent regimens, including: irinotecan 300mg/m2 IV once every 3 weeks, docetaxel 75mg/m2 IV once every 3 weeks, gemcitabine 1000g/m2 IV days 1 and 8 of a 3 week cycle, or pemetrexed 500 mg/m2 IV once every 3 weeks.
04/19/2014 04:02 AM