Phase I Study of Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy in Patients With Resectable Esophageal Cancer
18 Years
75 Years
Both
Esophageal Cancer, Malignant Neoplasm of Cardio-esophageal Junction of Stomach
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Evaluation of dose limiting toxicity (DLT)
Outcome Time Frame:
First 63 days
Safety Issue:
Yes
Principal Investigator
Bryan J Schneider, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Weill Medical College of Cornell University
Authority:
United States: Food and Drug Administration
Study ID:
1012011450
NCT ID:
NCT01386346
Start Date:
June 2011
Completion Date:
June 2013
Related Keywords:
- Esophageal Cancer
- Malignant Neoplasm of Cardio-esophageal Junction of Stomach
- gastroesophageal junction
- GEJ
- esophageal
- esophagus
- Neoplasms
- Esophageal Diseases
- Esophageal Neoplasms
- Stomach Neoplasms
Name | Location |
|---|---|
| Weill Cornell Medical College | New York, New York 10021 |
