Phase II Study of Ifosfamide and Doxorubicin in Patients With Refractory Nasopharyngeal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- To evaluate the overall response rate and toxicity including complete response rate, response duration, time to treatment failure, and survival of ifosfamide and doxorubicin as the second line chemotherapy for patients with advanced NPC
研究概览
简要总结
This research is to test the effectiveness and toxicity of both Ifosfamide and Doxorubicin. It also aims to explore the relationship between EBV DNA and clinical response in patients with advanced naso-pharyngeal cancer which has been previously treated with chemotherapy.
详细描述
Nasopharyngeal Cancer (NPC) is one of the common cancer in Southeast Asia. In this region NPC is associated with Epstein Barr Virus (EBV) chronic infection with EBV DNA identifiable in almost all the NPC tumors and patient's serum at the time of diagnosis. Chinese, especially cantonese has the highest incidence. Only about 30% of patients presents early disease and has a good treatment outcome (80% cure for stage I disease and 70% for stage II by radiation).
This research is to test the effectiveness and toxicity of both Ifosfamide and Doxorubicin. It also aims to explore the relationship between EBV DNA and clinical response in patients with advanced naso-pharyngeal cancer which has been previously treated with chemotherapy.
Investigators believe EBV infection is necessary to cause NPC and that EBV DNA levels in the blood may directly relate to the total size of the tumor. Because NPC patients in this situation have a poor outlook, we design this study to evaluate the combination of Ifosfamide and doxorubicin for further treatment. While this combination of medicines has been used in many other forms of cancer, it has not been tested in patients with NPC.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of NPC
- •Age > 18 years old
- •Measurable metastatic or recurrent disease (s)
- •Received one prior chemotherapy regimen for metastatic or recurrent NPC which relapsed or became refractory before entry.
- •ECOG PS 0, 1 or 2
- •WBC > 3,500/uL and ANC > 1,500/uL Platelet > 100,000/uL Creatinine - within normal limits SGOT < 3 X UNL Bilirubin < 2.0 mg/dL
- •Ejection fraction > 45% and no history of myocardial infarction or congestive heart failure in the last 6 months. No history of cardiac ventricular arrythmia or ventricle tachycardia, or uncontrolled atrial fibrillation or supraventricular tachycardia with hemodynamic compromising status.
- •Random blood glucose level < 250 mg
- •Signed informed consent
排除标准
- •Received more than one prior chemotherapy for metastatic or recurrent disease
- •Ejection fraction < 45%
- •WBC < 3,500/UL or ANC < 1,500/UL or P/t < 100,000/UL or SCOT> 3 x UNL or Bilirubin > 2.0 mg/dL or Creatinine > UNL
- •ECOG PS > 3
- •Hx of myocardial infarction within last 6 months
- •Random blood glucose level less than or equal 250 mg
研究组 & 干预措施
Ifosfamide and Doxorubicin
Single arm treatment with Ifosfamide and Doxorubicinin patients with Refractory Nasopharyngeal Carcinoma
干预措施: Ifosfamide (Drug)
Ifosfamide and Doxorubicin
Single arm treatment with Ifosfamide and Doxorubicinin patients with Refractory Nasopharyngeal Carcinoma
干预措施: Doxorubicin (Drug)
结局指标
主要结局
To evaluate the overall response rate and toxicity including complete response rate, response duration, time to treatment failure, and survival of ifosfamide and doxorubicin as the second line chemotherapy for patients with advanced NPC
时间窗: May 2008
Prematured termination, data is not analysed.
次要结局
- To correlate EBVDNA titer with clinical response(May 2008)