Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer

• Status: Completed
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to see whether giving azacitidine before each cycle of chemotherapy prior to surgery is safe.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Collaborator: Celgene Corporation
• Treatments: Azacitidine; Capecitabine; Epirubicin; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically confirmed adenocarcinoma or poorly differentiated carcinoma of the intrathoracic esophagus or gastroesophageal junction (GEJ) and deemed resectable by the thoracic surgeon.

• No prior chemotherapy for esophageal or GEJ cancer.

• ECOG Performance status 0-2.

• Adequate bone marrow, kidney and liver function.

• Ability to understand and the willingness to sign a written informed consent document.

• Subjects of child-bearing potential must agree to use effective means of contraception (men and women).

• Prior malignancy is acceptable if the subject is considered to be cured. In most cases this will mean a 5-year disease-free period.

Exclusion Criteria:

• Patients with cervical esophageal cancer or esophageal cancer with squamous cell carcinoma morphology.

• Subjects receiving any other investigational agent or received prior chemotherapy for esophageal or GEJ cancer.

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to azacitidine, epirubicin, oxaliplatin, capecitabine and mannitol.

• New York Heart Association (NYHA) Grade II or greater congestive heart failure.

• History of myocardial infarction or unstable angina within 6 months prior to study enrollment.

• Pregnant (positive pregnancy test) or lactating women.

• Patients with active infection, serious inter-current medical conditions.