Phase I Study of Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy in Patients With Resectable Esophageal Cancer
Currently patients with resectable (can be removed by surgery) esophageal cancer will
receive chemotherapy before surgery to try to shrink the tumor before it is removed. This
study will evaluate whether giving azacitidine before each cycle of chemotherapy to increase
the shrinkage of the tumor prior to surgery is safe.
Azacitidine is currently approved by the Food and Drug Administration (FDA) for treatment of
myelodysplastic syndrome (MDS). Azacitidine is not approved by the FDA for use in this
study and is therefore considered investigational. Because azacitidine has not been given
before in combination with epirubicin, oxaliplatin and capecitabine, we will also evaluate
the safety and tolerability of azacitidine and find out what dose of azacitidine is safe to
give with this chemotherapy.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluation of dose limiting toxicity (DLT)
First 63 days
Bryan J Schneider, M.D.
Weill Medical College of Cornell University
United States: Food and Drug Administration
|Weill Cornell Medical College||New York, New York 10021|