NCT00840450终止2 期
Phase II Study of Paclitaxel With Imatinib Mesylate (Gleevec) in Taxane-pretreated Ovarian and Other Cancers of Mullerian Origin
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- the Best Overall Clinical Response
研究概览
简要总结
This study is designed to determine whether the combination treatment of Paclitaxel and Gleevec on recurrent ovarian cancer patients or other cancers of mullerian origin will generate better clinical response than Paclitaxel alone.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients at least 18 years of age.
- •Histologically documented diagnosis of epithelial carcinoma arising in the ovary, fallopian tube or peritoneum, of any stage or grade at diagnosis. *Patients must have received initial cytoreductive surgery and chemotherapy with at least one platinum based chemotherapy regimen.
- •*Eligible platinum resistant patients will have failed no more than two additional non platinum cytotoxic regimens for their persistent or recurrent disease.
- •Measurable disease.
- •Performance status 0, 1, 2 (Eastern Cooperative Oncology Group) .
- •Adequate end organ function, defined as the following: total bilirubin < 1.5 x upper limit of normal (ULN), SGOT and SGPT < 2.5 x UNL, creatinine < 1.5 x ULN, ANC > 1.0 x 10E9/L, platelets > 100 x 10E9/L.
- •Written, voluntary informed consent.
排除标准
- •Patient has received any other anticancer treatment within 21 days of first day of study drug dosing and shown recovery of any recent drug-induced neutropenia and thrombocytopenia.
- •Patient has another primary malignancy that has required active intervention within 5 years, with the exception of basal cell skin cancer or a cervical carcinoma in situ.
- •Patient with Grade III/IV cardiac problems as defined by the New York Heart Association Criteria (i.e., congestive heart failure, myocardial infarction within 6 months of study).
- •Patient has a severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection).
- •Patients on coumadin-derived anticoagulants.
- •Patient with brain metastasis.
- •Chronic liver disease, Hep B or C.
- •Patient has a known diagnosis of human immunodeficiency virus (HIV) infection.
- •Patient received chemotherapy within 3 weeks -unless the disease is rapidly progressing.
- •Patient previously received radiotherapy to at least 25 % of the bone marrow.
- •Patient had a major surgery within 2 weeks prior to study entry.
- •Patient with any significant history of non-compliance to medical regimens or with inability to grant reliable informed consent.
- •Patient is on any drug that may interfere with Gleevec (e.g., Dilantin, Coumadin,or others on the list on page 33-37 of the protocol).
研究组 & 干预措施
Paclitaxel + Imatinib Mesylate (Gleevec)
Experimental
干预措施: Gleevec/Paclitaxel (Drug)
结局指标
主要结局
the Best Overall Clinical Response
时间窗: 12 weeks
This is defined as the percentage of participants who had either a complete response (CR) or a partial response (PR) as the best overall response according to Response Evaluation Criteria in Solid Tumors (RECIST) for measurable disease or CA-125 criteria for non-measurable disease. The response is evaluated at 12 weeks of treatment.
次要结局
- Progression-free-tolerance(12 weeks)
- Progression-free-survival at 12 Months(up to 12 months)
研究者
研究点 (1)
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