NCT00496301已完成2 期
Phase II Clinical Trial, Non-Randomized, Multicentre, on the Combination of Gemcitabine, Capecitabine and Sorafenib (Bay 43-9006) in Treatment of Patients With Unresectable and/or Metastatic Renal Cell Carcinoma (RCC)
Spanish Oncology Genito-Urinary Group20 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2006年11月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 20
- 主要终点
- Progression-free survival
研究概览
简要总结
Main Objective:
To evaluate progression-free survival in patients with unresectable renal cell carcinoma (RCC) treated with a combination of gemcitabine, capecitabine, and sorafenib.
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
- •Patients must give their written informed consent before any procedure related to the study is performed; therefore, it must be given at the selection visit. The patient must be informed that he has the right to withdraw from the study at any time, without any kind of prejudice.
- •Patients with renal clear cell carcinoma (RCC), unresectable and/or metastatic, histologically or cytologically documented (excluding the less common subtypes).
- •Patients must not be candidates for any immunotherapeutic treatment, according to the response predictive factors, or must be intolerant to immunotherapeutic treatment.
- •Patients classified as having median or low risk, according to Motzer's scoring.
- •Patients (men or women) with ages equal or superior to 18 years old.
- •Assessable or measurable disease.
- •Patients with adequate haematological function, defined as:
- •Neutrophils ≥ 1.5 x 10^9/L
- •Blood platelets ≥ 100 x 10^9/L
- •Haemoglobin ≥ 10 g/dl
- •Patients with adequate hepatic, renal, medullar and coagulation function, according to the following criteria:
- •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)
- •Amylase and lipase < 1.5 times the superior limit of normality
- •Serum creatinine < 2 times the superior limit of normality
- •TP or INR and TTP < 1.5 times the superior limit of normality. If patient is receiving anticoagulants, strict monitoring will be carried out, with evaluations on a weekly basis, at least, until the INR is stable, referring to a determination previous to dose administration, according to local standard care.
- •Patients with a life expectancy superior to 12 weeks, at least.
- •Patients may have received radiotherapy; however, this must not be the only target lesion.
- •Patients from both sexes must use adequate contraceptive methods (oral or injectable contraceptives, intrauterine device, condom, sterilization) whilst participating in the protocol. After the retreat of treatment with BAY 43-9006, the contraceptive methods must be used for 4 weeks in women and for 3 months in men.
- •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
- •Patients who do not give their written informed consent to participate in the study.
- •Patients with less common RCC subtypes, such as pure papillary cell tumours, Bellini carcinoma, medullary carcinoma or the oncocytic chromophobes and sarcomatoid variants, will be excluded from the study.
- •Patients that have received previous treatment with chemotherapy or that had tumours that evolved during or after immunotherapy treatment.
- •Patients that, due to their characteristics, may obtain a potential benefit from immunotherapy treatment.
- •Patients that have received previous anti-angiogenic treatment.
- •High-risk patients according to Motzer's classification.
- •Concomitant treatment with another chemotherapy or immunotherapy.
- •Arterial uncontrolled hypertension, which is defined as a systolic arterial pressure value > 150 mmHg or diastolic arterial pressure value > 90 mmHg, despite adequate medical treatment.
- •Patients with a primary cancer diagnosis different from RCC, except in situ cervical carcinoma, baseline cellular carcinomas or superficial bladder tumours, prostate cancer pT1 gleason < 6 or other malign tumours which have received curative treatment > 5 years previous to the inclusion in this study.
- •Cardiac arrhythmia antecedents, that require treatment with anti-arrhythmics (except for beta-blockers or digoxin), symptomatic coronary disease or ischemia (myocardial infarction in the previous 6 months) or congestive cardiac insufficiency > New York Heart Association (NYHA) class II
- •Patients with active bacterial or fungal infectious processes, which are considered severe from the clinical point of view (≥ Common Terminology Criteria from the National Cancer Institute [CTC from NCI] grade 2, version 3)
- •Patients that present previously known positive serology for HIV or chronic hepatitis B or C.
- •Antecedents of organ allograft.
- •Meningeal carcinomatosis or symptomatic uncontrolled cerebral disease.
- •Patients with epileptic disorders that require medication (such as antiepileptics).
- •All unstable conditions that could put the patient's security and/or his study accomplishment in danger.
- •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.
- •Patients that present any contraindication or allergy to the study's investigational product.
- •Patients that are participating or that have participated in any clinical trial in the 4 weeks previous to inclusion.
- •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.
结局指标
主要结局
Progression-free survival
时间窗: every 3 cycles and every two months in patients with "sorafenib" administered as monotherapy
次要结局
- security profile(every 3 cycles and every two months in patients with "sorafenib" administered as monotherapy)
- Objective response index (CR/PR) and tumor growth control (CR/PR/SD)(every three cycles and every two months in patients with "Sorafenib" treated as single agent)
- Duration of response(every three cycles and every two months in patients with "Sorafenib" treated as single agent)
- Global survival(At last contact date or death date)
- Time to progression(every three cycles and every two months in patients with "Sorafenib" treated as single agent)
研究者
研究点 (20)
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