Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer
NCT ID: NCT01386346
Last Updated: 2018-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2011-06-30
2018-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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
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
130 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.
Epirubicin
50 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.
Capecitabine
625 mg/m2 orally twice daily beginning on Day 3 or 5 and will be taken without interruption for each 21-day cycle.
Interventions
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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
130 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.
Epirubicin
50 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.
Capecitabine
625 mg/m2 orally twice daily beginning on Day 3 or 5 and will be taken without interruption for each 21-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Celgene Corporation
INDUSTRY
Weill Medical College of Cornell University
OTHER
Responsible Party
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Principal Investigators
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Manish Shah, M.D.
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Locations
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Weill Cornell Medical College
New York, New York, United States
Countries
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Other Identifiers
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VZ-ESOPH-PI-273
Identifier Type: OTHER
Identifier Source: secondary_id
1012011450
Identifier Type: -
Identifier Source: org_study_id