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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Weill Medical College of Cornell University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01386346
First received: May 10, 2011
Last updated: June 29, 2011
Last verified: June 2011
  Purpose

The purpose of this study is to see whether giving azacitidine before each cycle of chemotherapy prior to surgery is safe.


Condition Intervention Phase
Esophageal Cancer
Malignant Neoplasm of Cardio-esophageal Junction of Stomach
Drug: Azacitidine
Drug: Oxaliplatin
Drug: Epirubicin
Drug: Capecitabine
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy in Patients With Resectable Esophageal Cancer

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • Evaluation of dose limiting toxicity (DLT) [ Time Frame: First 63 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: June 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dose Level -1 Drug: Azacitidine
50 mg/m2 subcutaneous injection on Day 1-3 of a 21 day cycle. Repeat for a total of 3 cycles.
Other Names:
  • Vidaza®
  • 5-Azacitidine
Drug: Oxaliplatin
130 mg/m2 IV on Day 3 of each 21 day cycle. Repeat for a total of 3 cycles.
Drug: Epirubicin
50 mg/m2 IV on Day 3 of each 21 day cycle. Repeat for a total of 3 cycles.
Drug: Capecitabine
625 mg/m2 orally twice daily beginning on Day 3 and will be taken without interruption for each 21-day cycle.
Experimental: Dose Level 1 Drug: Azacitidine
75 mg/m2 subcutaneous injection on Day 1-3 of a 21 day cycle. Repeat for a total of 3 cycles.
Other Names:
  • Vidaza®
  • 5-Azacitidine
Drug: Oxaliplatin
130 mg/m2 IV on Day 3 of each 21 day cycle. Repeat for a total of 3 cycles.
Drug: Epirubicin
50 mg/m2 IV on Day 3 of each 21 day cycle. Repeat for a total of 3 cycles.
Drug: Capecitabine
625 mg/m2 orally twice daily beginning on Day 3 and will be taken without interruption for each 21-day cycle.
Experimental: Dose Level 2 Drug: Azacitidine
75 mg/m2 subcutaneous injection on Day 1-5 of a 21 day cycle. Repeat for a total of 3 cycles.
Other Names:
  • Vidaza®
  • 5-Azacitidine
Drug: Oxaliplatin
130 mg/m2 IV on Day 5 of each 21 day cycle. Repeat for a total of 3 cycles.
Drug: Epirubicin
50 mg/m2 IV on Day 5 of each 21 day cycle. Repeat for a total of 3 cycles.
Drug: Capecitabine
625 mg/m2 orally twice daily beginning on Day 5 and will be taken without interruption for each 21-day cycle.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01386346

Contacts
Contact: Bryan J Schneider, M.D. 646-962-2066 bjs2004@med.cornell.edu

Locations
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Gina Mileo, R.N.    212-746-5490    gjm2003@med.cornell.edu   
Sub-Investigator: Elizabeta Popa, M.D.         
Sub-Investigator: Allyson Ocean, M.D.         
Sub-Investigator: Ronald Scheff, M.D.         
Sub-Investigator: Nasser Altorki, M.D.         
Sub-Investigator: Jeffery Port, M.D.         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Bryan J Schneider, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Bryan Schneider, M.D., Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01386346     History of Changes
Other Study ID Numbers: 1012011450, VZ-ESOPH-PI-273
Study First Received: May 10, 2011
Last Updated: June 29, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Weill Medical College of Cornell University:
gastroesophageal junction
GEJ
esophageal
esophagus

Additional relevant MeSH terms:
Esophageal Neoplasms
Neoplasms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Stomach Diseases
Capecitabine
Fluorouracil
Azacitidine
Oxaliplatin
Epirubicin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014