NCT00926107终止2 期
Study of the mTOR Inhibitor Temsirolimus(CCI-779) in Patients With CA125 Only Relapse of Ovarian Cancer. A Phase II Study by the Hellenic Cooperative Oncology Group.
Hellenic Cooperative Oncology Group23 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2009年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 23
- 主要终点
- Clinical progression free survival.
研究概览
简要总结
The primary objective of this study is to determine the efficacy of Temsirolimus in patients with ovarian cancer with CA125 only relapse after first-line platinum-based 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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologic proof of epithelial ovarian,fallopian or peritoneal carcinoma of the following histological types:serous, endometrioid, mucinous, clear cell, low differentiation.
- •Age 18 years or older
- •Patients should have received first-line platinum based chemotherapy
- •Documented CA125 progression according to GCIC criteria.
- •No evidence of measurable or evaluable disease.
- •Provision of written informed consent
- •ECOG PS 0-2
- •Life expectancy of greater than 12 weeks
- •WBC>4000/μl, platelets > 100,000/μl and a hemoglobin level > 9.5 g/dl. Adequate baseline hepatic function, defined as a total bilirubin level < 2 mg/dl, SGPT and SGOT < 2.5 times the upper limits of normal. Creatinine < 1.5 mg/dl or creatinine clearance > 60 ml/min.
- •All females of childbearing potential must have a negative serum or urine pregnancy test obtained within 2 days prior to initiation of treatment and use effective contraception during the period of therapy.
- •At least one month from the last chemotherapy administration.
- •Provision of adequate paraffin-embedded tumor tissue for translational studies (optional).
排除标准
- •Other histological types (germ cell, granulose tumors etc)
- •History of atrial or ventricular arrhythmias and/or history of congestive heart failure, even if medically controlled. History of clinical and electrocardiographically documented myocardial infarction within the last 6 months from study entry
- •Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
- •Pre-existing motor or sensory neurotoxicity grade 2 according to the WHO criteria (intolerable paresthesia and/or marked motor loss or worse)
- •History of any treatment for CA125 relapse
- •Known, severe hypersensitivity to temsirolimus or any of the excipients of this product
- •Other coexisting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- •As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- •Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR.
- •Active infection or evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the patient to participate in the trial/ receive protocol treatment
- •Concomitant use of Cyp3 A inducers (phenytoin, carbamazepine, rifampicin, barbiturates or St John's Wort) should be avoided and as should treatment with strong CyP 3A inhibitors
- •Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.
结局指标
主要结局
Clinical progression free survival.
时间窗: 6-month
次要结局
- Progression Free Survival (PFS),Survival, CA125 response rate, Safety(Duration of the study)
研究者
研究点 (23)
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