JPRN-UMIN000009923已完成2 期
Phase II Trial of BK-UM against HB-EGF in combination with Gemcitabine in Patients with advanced or recurrent ovarian cancer - Phase II Trial of BK-UM against HB-EGF in combination with Gemcitabine
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 75years-old（—）
- 性别
- Female
入选标准
- 未提供
排除标准
- •1)Patient who have metastasis except for abdominal cavity or have the liver metastasis. 2)Patients who have serious illness or suspect to have serious illness mentioned below. 1.Patients with coronary heart disease or arrhythmia to need treatment. 2.Patient with left ventricle ejection fraction less than 50% in echocardiogram. 3.Patients who have cardiac dysfunction as grade III or IV of NYHA or have cardiac infarction within 6 months. 4. patient with pulmonary embolism. 5.Patients with decompensated cirrhosis. 6.Patients with interstitial pneumonia or pulmonary fibrosis, that is confirmed by chest X-ray and is associated with clinical symptoms. 7.The patients who need psychotic therapy or who take psychiatric medication. 8.Patients with poorly-controlled diabetes. 9.Patients with ileus or subileus. 10.Patients with active or poorly-controlled serious infection. 11.Patients with myelosuppression. 3)Patients with serious drug hypersensitivity. 4)Pregnant women, nursing mothers, or patients with chance of pregnancy. 5)Patients with a history of antiserum use. 6)Patient with multiple malignancies or with those history 5 years before agreement. 7)The patient who have a history of deferred treatment more than 6 weeks by hematotoxicity caused by the taxanes or the platinums use. 8)Patients who received the investigational drug 4 weeks before agreement. 9)Patients with a history of BK-UM use. 10)Patients undergoing radiation therapy to chest. 11)The patient that principal investigator or sub investigators judged the participation in this clinical trial to be inappropriate.
研究者
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