Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer
Completed · Phase 1
Conditions studied: Esophageal Cancer, Malignant Neoplasm of Cardio-esophageal Junction of Stomach
In brief
The purpose of this study is to see whether giving azacitidine before each cycle of chemotherapy prior to surgery is safe.
Key facts
- Study ID
- NCT01386346
- Run by
- Weill Medical College of Cornell University
- People needed
- 12
- Starts
- 2011-06-01
- Expected to finish
- 2018-09-01
- Last updated by the study team
- 2018-12-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Weill Cornell Medical College — New York, New York, United States
Full record on ClinicalTrials.gov
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