Clinical trial · Interventional
Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy for Resectable Esophageal Cancer
Phase I Study of Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy in Patients With Resectable Esophageal Cancer
NCT01386346CI-TRIAL-00036109VEOXcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to see whether giving azacitidine before each cycle of chemotherapy prior to surgery is safe.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
| Malignant Neoplasm of Cardio-esophageal Junction of Stomach | Esophageal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacitidine | Drug | Azacitidine | ALIAS |
| Capecitabine | Drug | Capecitabine | ALIAS |
| Epirubicin | Drug | Epirubicin | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- All subjects
- 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
- interventionNames
- Drug: Azacitidine
- Drug: Oxaliplatin
- Drug: Epirubicin
- Drug: Capecitabine
Primary outcomes (1)
- measure
- Evaluation of dose limiting toxicity (DLT)
- timeFrame
- First 63 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.