Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer
Conditions
Esophageal Cancer - Malignant Neoplasm of Cardio-esophageal Junction of Stomach
Conditions: official terms
Esophageal Neoplasms - Neoplasms - Stomach Neoplasms
Conditions: Keywords
gastroesophageal junction, GEJ, esophageal, esophagus
Study Type
Interventional
Study Phase
Phase 1
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Azacitidine Type: Drug
Name: Azacitidine Type: Drug
Name: Azacitidine Type: Drug
Name: Oxaliplatin Type: Drug
Name: Oxaliplatin Type: Drug
Name: Epirubicin Type: Drug
Name: Epirubicin Type: Drug
Name: Capecitabine Type: Drug
Name: Capecitabine Type: Drug
Overall Status
Recruiting
Summary
The purpose of this study is to see whether giving azacitidine before each cycle of chemotherapy prior to surgery is safe.
Detailed Description
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
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.
Location
Weill Cornell Medical College
New York, New York, United States
Status: Recruiting
Contact: Gina Mileo, R.N. - 212-746-5490 - gjm2003@med.cornell.edu
Start Date
June 2011
Completion Date
June 2013
Sponsors
Weill Medical College of Cornell University
Source
Weill Medical College of Cornell University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page