A Randomized Phase II Trial of Cytotoxic Chemotherapy With or Without Epigenetic Priming in Patients With Advanced Non-small Cell Lung Cancer
PRIMARY OBJECTIVES:
I. Percentage of patients progression-free at 6 months from time of randomization.
SECONDARY OBJECTIVES:
I. Progression-free survival (PFS). II. Overall Survival (OS).
OUTLINE: Patients are randomized to 1 of 3 treatment arms.
ARM A: Patients receive azacitidine subcutaneously (SC) on days 1-6 and 8-10 and entinostat
orally (PO) on days 3 and 10. Treatment repeats every 28 days for 2 courses in the absence
of disease progression or unacceptable toxicity. Patients with stable or progressive disease
receive chemotherapy of the treating oncologist's choice comprising irinotecan hydrochloride
intravenously (IV) on day 1, docetaxel IV on day 1, pemetrexed disodium IV on day 1, or
gemcitabine hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence
of disease progression or unacceptable toxicity.
ARM B: Patients receive azacitidine PO on days 1-21 and entinostat PO on days 3 and 10.
Treatment repeats every 28 days for 2 courses in the absence of disease progression or
unacceptable toxicity. Patients with stable or progressive disease receive chemotherapy of
the treating oncologist's choice as in Arm A.
ARM C: Patients receive chemotherapy of the treating oncologist's choice as in Arm A.
After completion of treatment, patients are followed up every 3-6 months for 24 months and
then yearly thereafter.
Powered by
SC CTSI