Phase I Study of Epigenetic Priming Using Azacitidine With Neoadjuvant Chemotherapy in Patients With Resectable Esophageal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evaluation of dose limiting toxicity (DLT)
研究概览
简要总结
The purpose of this study is to see whether giving azacitidine before each cycle of chemotherapy prior to surgery is safe.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Azacitidine (Drug)
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
干预措施: Oxaliplatin (Drug)
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
干预措施: Epirubicin (Drug)
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
干预措施: Capecitabine (Drug)
结局指标
主要结局
Evaluation of dose limiting toxicity (DLT)
时间窗: First 63 days
次要结局
未报告次要终点