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Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer

NCT01386346 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2018-12-12

No results posted yet for this study

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

Interventions

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.

DRUG

Oxaliplatin

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

DRUG

Epirubicin

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

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.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Manish Shah, M.D. · Weill Medical College of Cornell University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2014-08-31
Completion
2018-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01386346 on ClinicalTrials.gov