NCT00663559已完成2 期
Study Phase II to Determinate the Efficacy of Sunitinib in Patients With Renal Cells Carcinoma Metastasic or Locally Avanced in Patients Not Candidates to Curative Previous Nefrectomy
Spanish Oncology Genito-Urinary Group7 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2008年2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
- 59
- 试验地点
- 7
- 主要终点
- Progression-free survival
研究概览
简要总结
The purpose of this trial is to determinate the efficacy of Sunitinib in patients with renal cells carcinoma metastasic or locally avanced in patints not candidates to inicial curative nefrectomy.
详细描述
Study phase II in with one arm in patients with renal cells carcinoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •Patients must give their written informed consent before any procedure related to the study is performed.
- •Patients with renal clear cell carcinoma metastatic or locally advanced, histologically or cytologically documented.The patients with metastasic disease must be not condidated to curative nefrectomy as investigator criteria.
- •Assessable or measurable disease according to RECIST criteria. The lesions previosly radiated is not considered as target.
- •Ages equal or superior to 18 years old.
- •Patients with a life expectancy superior to 12 weeks.
- •Patients with adequate organic function, according to the following criteria:
- •. Medular reserve: Neutrophils absolute count≥ 1.5 x 10^9/L Platelets ≥ 100 x 10^9/L Haemoglobin ≥ 9g/dl
- •. Hepatic function: Total bilirubin < 1.5 times the superior limit of normality ALT and AST < 2.5 times the superior limit of normality (< 5 times the superior limit of normality in case of liver failure due to cancer)
- •. Seric Albumin ≥ 1.5 times the superior limit of normality
- •. Renal Function: Cleary creatinine > 30ml/min
- •. FEVI > LIN according to ECO or MUGA
- •Patients who are capable of accomplishing the study's requirements and without any impediments to follow the instructions while on study
排除标准
- •Pregnant or breastfeeding women. Women of fertile age must have a negative result in the pregnancy test performed 7 days before the beginning of the administration of the study medication. Both men and women included in the study must use an adequate contraceptive method.
- •Patients that have received sistemic treatment previous to metastasic disease.
- •Previous nefrectomy.
- •Mayor Surgery, radiotherapy or sistemic therapy received in the last 3 weeks previous to the inclusion of the patient in the study, except paliative radiotherapy upper no target lesions.
- •Radiotherapy upper > 25% bone marrow.
- •Patients that are participating in any clinical trial.
- •Patients with a primary cancer diagnosis in thast 3 years, except superficial basaliomas, superficial escamous carcinoma or in situ cervix carcinoma with aducuate treatment.
- •Following events in the last 12 months previous to begin the treatment: myocardial infarction, unstable o severe angina, coronary/periferic place of arterial by-pass, congestive cardiac insufficiency, brain-vascular accident included transitory ischemia or lung embolism.
- •Arterial uncontrolled hypertension nor controlated with drugs ( >150/100 mmHg despite adequate medical treatment).
- •Cardiac arrhythmia with grade NCI CTCAE ≥2, auricular fibrillation all grade and/or QTc interval> 450mseg in men and > 470 mseg in women.
- •Actually treatment with therapeutic dose with acenocumarol (except low dose for deep venous thrombosis).
- •Patients that present previously known positive serology for HIV.
- •Abuse of substances, clinical conditions, psychological or social, that may interfere with the patient's participation in the study or with the evaluation of the study's results.
研究组 & 干预措施
1
Other
This study has only one arm with Sunitinib
干预措施: Sunitinib (Drug)
结局指标
主要结局
Progression-free survival
时间窗: every 12 weeks
次要结局
- Global survival(At last contact date or death date)
- Response global(Every 12 weeks)
- Duration of response(Every 12 weeks)
- Security and tolerability of Sunitinib(Every 4 weeks)
研究者
研究点 (7)
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