Phase II Trial, Evaluating Efficacy of Temsirolimus (Torisel ®) in Second Line Therapy for Patients With Advanced Bladder Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 9
- 主要终点
- Non-progression Rate at 2 Months
研究概览
简要总结
In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival.
详细描述
In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival. This study will also search for genes involved in the response to 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
- •Men or women of at least 18 years of age
- •Histologically proven Bladder cancer
- •Locally advanced or metastatic disease (stage IV)
- •Functional status (ECOG / OMS) ≤ 2
- •Relapse after first-line chemotherapy
- •Measurable lesions (RECIST criteria)
- •Absence of anti-neoplasic treatment in the 4 weeks preceding inclusion.
- •Biological levels :
- •Neutrophil count >1,5.109/L.
- •Platelets >100.109/L
- •Total serum bilirubin < 1.5 × ULN
- •Clearance of créatinine 40 ml/mm
- •If not liver metastasis alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <2.5 × ULN
- •With liver alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <5 × ULN
- •Signed informed consent
- •Both women and men must agree to use a medically acceptable method of contraception throughout the study. Women of childbearing potential must have a negative serum pregnancy test of or less than 7 days before the first perfusion of study.
- •France only : Patients affiliated to a social security program
排除标准
- •Presence of metastatic brain or meningeal tumors on selection scanner, weither symptomatic or asymptomatic
- •Chemotherapy, immunotherapy, or radiotherapy within 4 weeks of inclusion
- •Known hypersensitivity to temsirolimus, or its metabolites (as sirolimus), or polysorbate 80 or to their excipients
- •Previous malignancy (except for cervical carcinoma in situ, basal cell carcinoma curatively treated) or incidental (≤ pT2) prostate cancer found on a radical cystoprostatectomy material
- •The drugs known as CYP3A4/5 inhibitors or inducers will specifically be excluded on the 30th day ( or at least 7 halves-lives, according to the shortest duration) before the first perfusion and throughout the study. Any food known to inhibit CYP3A4/5 (for example grapefruit, grapefruit juice, star-fruit or star-fruit juice) will also be purposely excluded.
- •Auto-immune pathology, psychiatric or neurological disorder
- •Any unstable medical condition
- •Unstable cardiac disease
- •Severe renal failure
- •Unstable diabetes
- •Pregnancy
- •Patient enrolled in another therapeutic clinical trial
- •Patient unable to follow and comply with the study procedures because of any geographical, social or medical condition
- •Patient partially or totally deprived of his civil rights
研究组 & 干预措施
Temsirolimus
Temsirolimus was administered intravenously at a dose of 25 mg in a weekly 30 min infusion and was associated to anti-H1 treatment. One cycle corresponded to 4 weeks of treatment.
干预措施: Temsirolimus (Drug)
结局指标
主要结局
Non-progression Rate at 2 Months
时间窗: 2 months
Non-progression rate is defined as the rate of participants in complete or partial response or stable disease according to RECIST V1.1. Complete response is defined as the disappearance of all target lesions, partial response is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters and stable disease occurs when neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progression, taking as reference the smallest sum diameters while on study.
次要结局
- Overall Survival(Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months))
- Progression-free Survival(Through Database Cutoff Date of 23-Jan-2015 (up to approximately 5 years and 7 months - median follow-up time of 14 months))