NCT01386346 - Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

June 30, 2011

Primary Completion Date

August 31, 2014

Study Completion Date

September 30, 2018

Conditions

Esophageal CancerMalignant Neoplasm of Cardio-esophageal Junction of Stomach

Interventions

DRUG

Azacitidine

Dose level -1: 50 mg/m2 subcutaneous injection on Day 1-3 of a 21 day cycle. Repeat for a total of 3 cycles. Dose level 1: 75 mg/m2 subcutaneous injection on Day 1-3 of a 21 day cycle. Repeat for a total of 3 cycles. Dose level 2: 75 mg/m2 subcutaneous injection on Day 1-5 of a 21 day cycle. Repeat for a total of 3 cycles.

DRUG

Oxaliplatin

130 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.

DRUG

Epirubicin

50 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.

DRUG

Capecitabine

625 mg/m2 orally twice daily beginning on Day 3 or 5 and will be taken without interruption for each 21-day cycle.

Trial Locations (1)

10021

Weill Cornell Medical College, New York