Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer

NCT01386346 | Completed Phase 1 DMC

• 2 other identifiers: 1012011450VZ-ESOPH-PI-273
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

gastroesophageal junction; GEJ; esophageal; esophagus

Outcome Measures

Primary Outcomes (1)

• Evaluation of dose limiting toxicity (DLT)

  First 63 days

Study Arms (1)

All subjects

EXPERIMENTAL

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; Drug: Oxaliplatin; Drug: Epirubicin; Drug: Capecitabine

Interventions

Azacitidine DRUG

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.

Also known as: Vidaza®, 5-Azacitidine

All subjects

Oxaliplatin DRUG

130 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.

Also known as: Eloxatin

All subjects

Epirubicin DRUG

50 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.

Also known as: Ellence

All subjects

Capecitabine DRUG

625 mg/m2 orally twice daily beginning on Day 3 or 5 and will be taken without interruption for each 21-day cycle.

Also known as: Xeolda

All subjects

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Celgene Corporation: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Azacitidine; Oxaliplatin; Epirubicin; Capecitabine

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Coordination Complexes; Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Deoxycytidine; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides

Study Officials

• Manish Shah, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: July 1, 2011
• Study Start: June 1, 2011
• Primary Completion: August 1, 2014
• Study Completion: September 1, 2018
• Last Updated: December 12, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)