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

• Sponsor: Weill Medical College of Cornell University (Other)
• Overall Status: Completed
• CT.gov ID: NCT01386346
• Collaborator: Celgene Corporation (Industry)
• Enrollment: 12
• Location: 1
• Arm: 1
• Actual Duration (Months): 87
• Patients Per Site Per Month: 0.1

Study Details

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.

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

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 Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase I Study of Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy in Patients With Resectable Esophageal Cancer
• Actual Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Sep 1, 2018

Arms and Interventions

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

Drug: 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.; Other Names: Vidaza® 5-Azacitidine ; Drug: Oxaliplatin; 130 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.; Other Names: Eloxatin ; Drug: Epirubicin; 50 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.; Other Names: Ellence ; Drug: 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 Names: Xeolda

Outcome Measures

Primary Outcome Measures

1. Evaluation of dose limiting toxicity (DLT) [First 63 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medical College	New York	New York	United States	10021

Sponsors and Collaborators

• Weill Medical College of Cornell University
• Celgene Corporation

Investigators

• Principal Investigator: Manish Shah, M.D., Weill Medical College of Cornell University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Weill Medical College of Cornell University
• ClinicalTrials.gov Identifier: NCT01386346
• Other Study ID Numbers: 1012011450; VZ-ESOPH-PI-273
• First Posted: Jul 1, 2011
• Last Update Posted: Dec 12, 2018
• Last Verified: Dec 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Weill Medical College of Cornell University: gastroesophageal junction; GEJ; esophageal; esophagus
• Additional relevant MeSH terms: Esophageal Neoplasms; Neoplasms; Capecitabine; Azacitidine; Oxaliplatin; Epirubicin

Study Results

No Results Posted as of Dec 12, 2018