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Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer (VEOX)

Primary Purpose

Esophageal Cancer, Malignant Neoplasm of Cardio-esophageal Junction of Stomach

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Azacitidine
Oxaliplatin
Epirubicin
Capecitabine
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring gastroesophageal junction, GEJ, esophageal, esophagus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Weill Cornell Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All subjects

Arm Description

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

Outcomes

Primary Outcome Measures

Evaluation of dose limiting toxicity (DLT)

Secondary Outcome Measures

Full Information

First Posted
May 10, 2011
Last Updated
December 10, 2018
Sponsor
Weill Medical College of Cornell University
Collaborators
Celgene Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01386346
Brief Title
Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer
Acronym
VEOX
Official Title
Phase I Study of Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy in Patients With Resectable Esophageal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
Collaborators
Celgene Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Malignant Neoplasm of Cardio-esophageal Junction of Stomach
Keywords
gastroesophageal junction, GEJ, esophageal, esophagus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
All subjects
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Azacitidine
Other Intervention Name(s)
Vidaza®, 5-Azacitidine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Other Intervention Name(s)
Eloxatin
Intervention Description
130 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.
Intervention Type
Drug
Intervention Name(s)
Epirubicin
Other Intervention Name(s)
Ellence
Intervention Description
50 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Other Intervention Name(s)
Xeolda
Intervention Description
625 mg/m2 orally twice daily beginning on Day 3 or 5 and will be taken without interruption for each 21-day cycle.
Primary Outcome Measure Information:
Title
Evaluation of dose limiting toxicity (DLT)
Time Frame
First 63 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manish Shah, M.D.
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer

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