Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer (VEOX)
Phase I Study of Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy in Patients With Resectable Esophageal Cancer
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Weill Cornell Medical College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: All subjects
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. Oxaliplatin on Day 1 130mg/m2 Epirubicin on Day 1 50mg/m2 Capecitabine 625 mg/m2 |
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.
Other Names:
130 mg/m2 IV on Day 3 or 5 of each 21 day cycle.
Repeat for a total of 3 cycles.
Other Names:
50 mg/m2 IV on Day 3 or 5 of each 21 day cycle.
Repeat for a total of 3 cycles.
Other Names:
625 mg/m2 orally twice daily beginning on Day 3 or 5 and will be taken without interruption for each 21-day cycle.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Evaluation of dose limiting toxicity (DLT)
Time Frame: First 63 days
|
First 63 days
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Manish Shah, M.D., Weill Medical College of Cornell University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms
- Esophageal Neoplasms
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Capecitabine
- Epirubicin
- Oxaliplatin
- Azacitidine
Other Study ID Numbers
- 1012011450
- VZ-ESOPH-PI-273 (Other Identifier: Celgene Corporation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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