EUCTR2008-007925-38-GR进行中（未招募）不适用
STUDY OF THE mTOR INHIBITOR TEMSIROLIMUS (CCI-779) IN PATIENTS WITH CA125 ONLY RELAPSE OF OVARIAN CANCERA phase II study by the Hellenic Cooperative Oncology Group
Hellenic Cooperative Oncology Group0 个研究点目标入组 38 人开始时间: 2009年10月29日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Histologic proof of epithelial ovarian carcinoma
- •2. Age 18 years or older
- •3.Patients should have received first-line platinum based chemotherapy
- •4. Documented CA125 progression according to GCIC criteria.
- •5. No evidence of measurable or evaluable disease.
- •6.Provision of written informed consent
- •7.ECOG PS 0-2
- •8.Life expectancy of greater than 12 weeks
- •9.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.
- •10. All patients of childbearing potential must have a negative serum or urine pregnancy test obtained within 2 days prior to initiation of treatment and use adequate methods of contraception
- •12.At least one month from the last chemotherapy administration.
- •11.Provision of adequate paraffin-embedded tumor tissue for translational studies (optional).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Other histological types (germ cell, granulose tumors etc)
- •2. 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
- •3. Any evidence of clinically active interstitial lung disease (patients with chronic stable radiographic changes who are asymptomatic need not be excluded)
- •4. Pre-existing motor or sensory neurotoxicity grade 2 according to the WHO criteria (intolerable paresthesia and/or marked motor loss or worse)
- •5. History of any treatment for CA125 relapse
- •6. Known, severe hypersensitivity to temsirolimus or any of the excipients of this product
- •7. Other coexisting malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ
- •8. Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
- •9. As judged by the investigator, any evidence of severe or uncontrolled systemic disease (eg unstable or uncompensated respiratory, cardiac, hepatic or renal disease)
- •10. Alanine amino transferase (ALT) or aspartate amino transferase (AST) greater than 2.5 times the ULRR
- •12. 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
- •13. 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
- •15. Treatment with a non-approved or investigational drug within 30 days before Day 1 of trial treatment.
研究者
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