NCT00792025已完成2 期
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
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Objective response as assessed by RECIST criteria
研究概览
简要总结
RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying sunitinib to see how well it works as second-line therapy in treating patients with locally advanced or metastatic transitional cell cancer.
详细描述
OBJECTIVES:
Primary
- To determine the objective tumor response rate according to RECIST criteria in patients with locally advanced or metastatic transitional cell carcinoma of the urothelium treated with sunitinib malate who failed or progressed after first-line chemotherapy .
Secondary
- To determine the safety of this drug.
- To determine the time to response and duration of response.
- To determine the progression-free survival and overall survival of these patients.
- To evaluate the quality of life of these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed transitional cell cancer of the urothelium
- •Advanced or metastatic disease
- •Disease failed or progressed after first-line chemotherapy
- •At least 1 non-irradiated measurable lesion assessed by CT scan or MRI according to RECIST
- •No progressive brain metastases
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-2
- •ANC ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Hemoglobin ≥ 8g/dL
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in presence of liver metastases)
- •Creatinine clearance ≥ 40 mL/min
- •PTT and INR ≤ 1.5 times ULN
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during study treatment
- •No uncontrolled high BP, defined as > 150/100 mm Hg despite treatment
- •No diagnosis of a second malignancy within the past 5 years, except for basal cell or squamous cell carcinoma of the skin, incidental PT2 prostate cancer found on radical cystoprostatectomy material, or carcinoma in situ of the cervix, that has been adequately treated with no evidence of recurrence in the past 12 months
- •None of the following within the past 12 months:
- •Myocardial infarction
- •Severe/unstable angina pectoris
- •Coronary artery bypass graft
- •Symptomatic congestive heart failure
- •Cerebrovascular accident
- •Transient ischemic attack
- •Pulmonary embolism
- •At least 6 months since deep vein thrombosis
- •No NCI CTCAE grade 3 hemorrhage within the past 4 weeks
- •No pre-existing neuropathy ≥ NCI CTCAE grade 2
- •No history of interstitial pneumonitis or pulmonary fibrosis
- •No ongoing cardiac arrhythmias ≥ NCI CTCAE grade 2, atrial fibrillation of any grade, or prolongation of the QTc interval (> 450 msec for males or > 470 msec for females)
- •No ongoing active infection
- •No patients deprived of liberty or who are under supervision (including a trusteeship)
- •No psychological, familial, sociological, or geographic condition potentially hampering compliance with study treatment and follow-up
- •Patients must be affiliated to a social security system
- •PRIOR CONCURRENT THERAPY:
- •Prior platinum-based therapy allowed
- •No prior sunitinib malate
- •No prior radiotherapy to ≥ 25% of marrow producing area
- •Prior neoadjuvant or adjuvant chemotherapy allowed
- •More than 2 weeks since prior and no concurrent oral anticoagulant agents at therapeutic doses
- •Low molecular weight heparin allowed
- •At least 30 days since prior chemotherapy or radiotherapy and recovered
- •No other concurrent anticancer treatment, including experimental agents, or participation in another investigational trial
排除标准
- 未提供
结局指标
主要结局
Objective response as assessed by RECIST criteria
次要结局
- Progression-free survival
- Overall survival
- Time to response and duration of response
- Safety
- Quality of life
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Sunitinib in Treating Patients With Kidney Cancer That Has Spread to the BrainKidney CancerMetastatic CancerNCT00814021Institut Claudius Regaud21
已完成
2 期
Sunitinib in Treating Patients With Metastatic, Locally Advanced, or Locally Recurrent SarcomasDesmoid TumorEndometrial CancerAdult Malignant Fibrous Histiocytoma of BoneSmall Intestine CancerOvarian CancerSarcomaNCT00474994Memorial Sloan Kettering Cancer Center53
终止
2 期
Sunitinib Malate After Stereotactic Radiosurgery in Treating Patients With Newly Diagnosed Brain MetastasesMetastatic CancerUnspecified Adult Solid Tumor, Protocol SpecificCognitive/Functional EffectsNCT00910039Case Comprehensive Cancer Center14
Unknown
2 期
Sunitinib as Maintenance Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung CancerNon-small Cell Lung CancerNCT01210053Third Military Medical University30
已完成
2 期
Sunitinib in Treating Patients With Metastatic Germ Cell Tumors That Have Relapsed or Not Responded to TreatmentTeratomaExtragonadal Germ Cell TumorTesticular Germ Cell TumorOvarian CancerNCT00453310Memorial Sloan Kettering Cancer Center10