NCT01264341终止2 期
Phase II Study of Efficacy and Safety of Bevacizumab in Combination With Temsirolimus, After 1st Line Anti-VEGF Treatment in Patients With Advanced Renal Cancer
Hellenic Cooperative Oncology Group8 个研究点 分布在 1 个国家目标入组 39 人开始时间: 2010年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 39
- 试验地点
- 8
- 主要终点
- 6-month Progression Free Survival (PFS)
研究概览
简要总结
The purpose of this study is to determine whether the combination of bevacizumab/temsirolimus is effective in patients with advanced renal carcinoma progressing after anti-VEGF treatment
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
- •Adult patients (18th year of age completed)
- •Signed and dated written informed consent form prior to any procedures related to this protocol.
- •Histologically confirmed advanced clear cell renal cancer.
- •Measurable disease.
- •Failure of first line anti-VEGF treatment.
- •Performance status 0-2, according to Eastern Cooperative Oncology Group (ECOG) .
- •Satisfactory hematological parameters:
- •White blood cell count > 4000 mm
- •Platelet count 100000/mm
- •Neutrophil blood cell count > 1200/ mm3 .
- •Hemoglobin > 9,0 g/dL (can be achieved with red blood cell transfusion).
- •Satisfactory biochemical parameters:
- •Serum creatinine < 2 x Upper Limit of Normal(ULN)
- •Aspartate Aminotransferase (AST)<2,5 x ULN
- •Alanine Transaminase (ALT)< 2,5 x ULN.
- •Bilirubin <2 x ULN
- •(For female patients) Absence of pregnancy (negative pregnancy test for women of reproductive age before enrollment).
- •(For female patients) Non-lactating women.
- •Use of efficient contraceptive measures (women and men) to prevent possible pregnancy of female patient or female partner of a male patient during treatment and until 6 months after the end of treatment.
排除标准
- •Prior treatment with mTOR inhibitor.
- •Major surgery (including open biopsy) or insufficient recovery or existence of major trauma within 4 weeks before enrollment.
- •Uncontrolled hypertension.
- •Active infection requiring systemic treatment within 4 weeks prior to enrollment.
- •Minor surgery (for instance, catheter placement) within 2 days before enrollment.
- •Scheduled major surgery within the treatment period.
- •Medical history in the last 6 months prior to enrollment of significant cardiovascular disease, diabetes, cardiac infarction, unstable angina, uncontrolled arrhythmia or significant heart failure.
- •Indications of uncontrolled metastases or disease progression in CNS lesions (the suspicion of uncontrolled metastases or disease progression should be eliminated by imaging techniques within 14 days prior to enrollment).
- •Medical history in the last 5 years prior to enrollment of any other malignancies (excluding the basal or squamous skin cell carcinoma or in situ carcinoma of the cervix).
- •History of non-healing wound including active gastric ulcer.
- •History of fistula in the last 6 months prior to enrollment.
- •History of gastrointestinal perforations.
- •Patient incapacity (for psychiatric or social reasons) to conform with the protocol.
- •History of hemorrhagic predisposition.
- •History of hypersensitivity to the medications under investigation.
- •Significant proteinurea.
- •Prior immunotherapy within 4 weeks prior to enrollment.
- •Prior radiation treatment within 2 weeks prior to enrollment.
- •Concomitant medication with inducers or strong inhibitors of the coenzyme CYP3A4 (see Appendix 5 for an indicative list of active compounds).
- •Concurrent participation in other interventional clinical trials with investigational medicinal products.
- •History of chronic interstitial lung disease.
研究组 & 干预措施
Bevacizumab combined with temsirolimus
Experimental
Bevacizumab 10mg/kg intravenous every 2 weeks Temsirolimus 25mg intravenous once weekly
干预措施: Bevacizumab (Drug)
Bevacizumab combined with temsirolimus
Experimental
Bevacizumab 10mg/kg intravenous every 2 weeks Temsirolimus 25mg intravenous once weekly
干预措施: Temsirolimus (Drug)
结局指标
主要结局
6-month Progression Free Survival (PFS)
时间窗: 32 months
Proportion of patients who are progression-free at 6month evaluation from treatment initiation
次要结局
- Quality of Life (QoL) assessment(At baseline and every 8 weeks during treatment)
- Adverse Events (AEs) of all participants will be recorded and assessed upon signature of the informed consent form, until 30 days after the last administration of study treatment.(3 years)
- Investigation of antiangiogenic factors (FGF, VEGF, VEGFRR)(36 months)
- Progression Free Survival (PFS)(Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks)
- Overall Survival (OS)(48 months)
- Response Rate (RR)(Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks)
- Tumor Shrinkage(Tumor assessments will be performed every 8 weeks during treatment and at discontinuation, unless it was performed within the last 4 weeks)
研究者
研究点 (8)
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