EUCTR2008-001004-22-FR进行中（未招募）不适用
A multicentre phase II trial to determine the efficacy of the anti-tyrosine kinase sunitinib (SUTENT®) as second line therapy in patients with transitional cell carcinoma (TCC) of the urothelium which failed or progressed after first line chemotherapy for advanced or metastatic disease. - VESS
Centre René Huguenin0 个研究点开始时间: 2008年3月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Histologically proven advanced transitional cell carcinoma of the urothelium
- •2. Progressive disease after one line of chemotherapy for locally advanced or metastatic disease
- •3. Patients treated with neoadjuvant or adjuvant chemotherapy before may be included if the perioperative chemotherapy was performed at least one year before the chemotherapy for metastatic or loco-regional relapse
- •4. Previous treatment with a platinum derivative
- •5. Previous chemotherapy or radiotherapy must have been stopped 30 days before first dose of study treatment and patients must have recovered from any serious side effects of treatment
- •6. Patients must have one measurable lesion defined by RECIST criteria not previously irradiated, assessed by conventional CT-scan ou MRI performed < 28 days before first day of study drug administration
- •7. Patient aged 18 years old or more
- •8. Patients must have a performance Status < 2 on the Eastern Cooperative Oncology Group Scale
- •9. Adequate haematological function (ANC > 1.5 x 109/L; Platelets = 100 x 109/L and Hb = 8 g/dL)
- •10. Adequate hepatic function: total bilirubin = 1.5 times the upper limit of normal (ULN) ASAT and ALAT = 2.5 x ULN or = 5 x UNL in presence of liver metastase
- •11. Adequate renal function: calculated creatinine clearance = 40 ml/min according to Cockcroft and Gault formula
- •12. Partial thromboplastin time (PTT) = 1.5 x UNL and INR = 1.5
- •13. Women and men with reproductive potential must use medically acceptable contraceptive method
- •14. Patients must be affiliated to a Social Security System
- •15. Patient Information and written informed consent form signed
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous chemotherapy in an adjuvant or neoadjuvant setting only
- •2. Prior treatment with radiotherapy involving more than 25 % of marrow producing area
- •3. Concurrent anti-cancer treatment in an another investigational trial
- •4. Concurrent anti-cancer treatment
- •5. Prior treatment on sunitinib
- •6. Uncontrolled high blood pressure defined as >150/100 mm/Hg despite treatment
- •7. Progressives brain metastases
- •8. Any of the following within the 12 months prior to study drug administration:
- •a. myocardial infarction,
- •b. severe/unstable angina pectoris, coronary artery bypass graft,
- •c. symptomatic congestive heart failure,
- •d. cerebrovascular accident,
- •e. including transient ischemic attack,
- •f. pulmonary embolism
- •9. Ongoing cardiac dysrhythmias of NCI CTCAE grade = 2, atrial fibrillation of any grade, or prolongation of the QTc interval to > 450 msec for males or > 470 msec for females
- •10. Ongoing active infection
- •11. Treatment with anticoagulant agents at therapeutic doses currently or within 2 weeks prior to first day of sunitinib administration. Low molecular weight heparin is allowed.
- •12. NCI CTC Grade 3 hemorrhage < 4 weeks of starting study treatment
- •13. History of interstitial pneumonitis or pulmonary fibrosis
- •14. History of deep venous thrombosis within 6 months prior to entry on study
- •15. Pre-existing neuropathy of NCI CTCAE grade = 2
- •16. Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, incidental PT2 prostate cancer found on a radical cystoprostatectomy material; or carcinoma in situ of the cervix that has been adequately treated with no evidence of recurrent disease for 12 months
- •17. Pregnant women, women who are likely to be pregnant or are breastfeeding
- •18. Individuals deprived of liberty or placed under the authority of a tutor
- •19. Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and the follow-up
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