NCT00979966已完成2 期
Prospective Randomized Phase-II Trial With Temsirolimus Versus Sunitinib in Previously Untreated Patients With Advanced or Metastatic Non-Clear Cell Renal Carcinoma
Central European Society for Anticancer Drug Research14 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2009年7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
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 14
- 主要终点
- Time to progression
研究概览
简要总结
This will be a prospective, open-label, randomized multicenter phase-II study to evaluate progression free survival (PFS) in patients with locally advanced or metastatic non-clear cell renal cell cancer (ncc-RCC) receiving Temsirolimus in comparison to Sunitinib.
In most clinical trials in renal cell carcinoma (RCC), clear cell RCC have been included exclusively. There are only some limited data on the efficacy of Temsirolimus or Sunitinib in ncc-RCC showing interesting response rates for both agents. However, randomized clinical trials in this specific patient population have not yet been performed.
In the proposed study a comparison Temsirolimus and Sunitinib is scheduled in first line therapy of ncc-RCC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 males and females: ≥18 years of age.
- •Locally advanced or metastatic, histological confirmed, non-clear cell RCC of all subtypes. Patients must have advanced non-clear cell of one of the following subtypes: papillary, chromophobe, collecting duct carcinoma (CDC), renal medullary carcinoma (RMC), or unclassified.
- •Patients with measurable disease (at least one uni-dimensionally measurable target lesion by CT-scan or MRI) according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1) If prior palliative radiotherapy to metastatic lesions: ≥ 1 measurable lesion that has not been irradiated.
- •PS 0-2 ECOG
- •Signed written informed consent.
- •White blood cell count (WBC) ≥4x10*9/L with neutrophils ≥1.5 x 10*9/L, platelet count ≥100x10*9/L, hemoglobin ≥9 g/dL.]
- •Total bilirubin <2 x upper limit of normal.
- •AST and ALT <2.5 x upper limit of normal, or <5 x upper limit of normal in case of liver metastases.
- •Serum creatinine <2.0 x upper limit of normal.
- •Normal ECG without QT prolongation (QTc < 450msec).
- •Adequate cardiac function (left ventricular ejection fraction > 40% as assessed by ECHO.
排除标准
- •Predominant clear-cell RCC
- •Resectability or other curative options
- •Any investigational drug within the 30 days before inclusion.
- •Prior systemic treatment for their RCC.
- •Known or suspected allergy or hypersensitivity reaction to any of the components of study treatments.
- •Radiotherapy within the last 4 weeks.
- •Pregnancy (absence to be confirmed by beta-hCG test) or lactation period.
- •Men or women of child-bearing potential who are sexually active and unwilling to use a medically acceptable method of contraception during the trial.
- •Clinically symptomatic brain or meningeal metastasis. (known or suspected)
- •Cardiac arrhythmias requiring anti-arrhythmics (excluding beta blockers or digoxin).
- •History of any of the following cardiac events within the past 6 months:
- •myocardial infarction (including severe/unstable angina),
- •coronary/peripheral artery bypass graft,
- •congestive heart failure (CHF),
- •cerebrovascular accident,
- •transient ischemic attack,
- •pulmonary embolism.
- •No hemorrhage ≥ grade 3 within the past 4 weeks
- •Uncontrolled severe hypertension (failure of diastolic blood pressure to fall below 90 mm Hg despite the use of ≥3 anti-hypertensive drugs
- •History of relevant pulmonary hypertension or interstitial lung disease.
- •Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease or chronic diarrhea
- •Previous malignancy (other than renal cancer cancer) in the last 5 years except basal cell cancer of the skin, pre-invasive cancer of the cervix or superficial bladder tumor [Ta, Tis and T1].
- •History of organ allograft
- •Significant disease which, in the investigator's opinion would exclude the patient from the study
- •Patients with seizure and epileptic disorder or other conditions requiring medication (such as phenytoin, carbamazepin, phenobarbital)
- •Patients under strong inducers or inhibitors to CYP Isoenzymes
- •Patients with hypersensitivity to the antihistamine or patients who cannot receive the antihistamine for other medical reasons
- •Patients requiring long-term cortisone therapy
- •Patients requiring oral anticoagulation treatment, such as marcoumar. (Anticoagulation treatment with heparin or low molecular weight heparin [LMWH] is allowed provided that close monitoring is performed).
- •Surgery within at least 2 weeks prior to randomization
- •HIV seropositivity.
- •Abnormal pulmonary function (DLCO < 50%). [Pulmonary function tests need only to be performed if abnormal pulmonary function present in medical history].
- •Poorly controlled diabetes mellitus.
- •Liver cirrhosis, chronic hepatitis
- •Legal incapacity or limited legal capacity
- •Known alcohol or drug abuse.
- •Medical or psychological conditions that would not permit the patient to complete the study or sign informed consent.
研究组 & 干预措施
A
Experimental
Temsirolimus
干预措施: Temsirolimus (Drug)
B
Experimental
Sunitinib
干预措施: Sunitinib (Drug)
结局指标
主要结局
Time to progression
时间窗: 7-11 months expected
次要结局
- Objective response(7-11 months expected)
- safety assessed using CTCAE v3.0 and safety assessed according to reported SAEs(8-12 months (treatment duration + 1 months))
- one year progression free survival rate (1YPFSR)(1 year)
- overall survival (OS)(will be evaluated in 2013)
研究者
研究点 (14)
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