NCT01222676Unknown2 期
A Phase II Study of Neoadjuvant Cisplatin and Gemcitabine Plus Sorafenib for Patients With Transitional-Cell Carcinoma of the Bladder
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2010年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Pathological complete response
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as cisplatin and gemcitabine hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. Giving cisplatin and gemcitabine hydrochloride together with sorafenib tosylate may kill more tumor cells. Giving them before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving cisplatin and gemcitabine hydrochloride together with sorafenib tosylate works in treating patients with node-negative transitional cell cancer of the bladder.
详细描述
OBJECTIVES:
Primary
- To evaluate the activity (pathological complete response) of neoadjuvant cisplatin and gemcitabine hydrochloride in combination with sorafenib tosylate in patients with muscle-invasive, node-negative transitional cell carcinoma of the bladder.
Secondary
- To evaluate the safety and tolerability of this regimen in these patients.
- To determine the potential biological correlates of disease response and drug activity in tumor tissue samples before and after treatment.
- To evaluate the correlation between fludeoxyglucose F 18 positron emission tomography (18FDG-PET) and standard computed tomography (CT) results and the ability of changes of 18FDG-PET (as measured by EORTC criteria for response) to predict subsequent favorable response to treatment (pathological complete response rate and progression-free survival).
研究设计
- 研究类型
- Interventional
- 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:
- •Confirmed transitional cell carcinoma (TCC) of the bladder at the time of diagnostic transurethral resection of the bladder tumor (TURB)*
- •Muscle-invasive (T ≥ 2) disease at TURB OR clinical stage T3 or T4 disease (e.g., T2 patients will not be eligible without a histological documentation of invasive disease)
- •NOTE: *Confirmation of TCC histology based on pathologic review at Fondazione Istituto Nazionale dei Tumori Milan will be required in all cases.
- •Clinically node-negative (cN0) disease
- •PATIENT CHARACTERISTICS:
- •ECOG performance status 0-1
- •WBC ≥ 2,000/µL
- •ANC ≥ 1,500/µL
- •Platelet count ≥ 100,000/µL
- •Serum creatinine ≤ 1.5 mg/dL
- •AST/ALT < 2.5 times upper limit of normal (ULN) (< 5 times ULN if due to hepatic metastases)
- •Total bilirubin < 1.5 times ULN
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •Negative serology for the following infectious diseases:
- •HIV type 1 or 2
- •Hepatitis B surface antigen (active carriers)
- •Hepatitis C
- •PRIOR CONCURRENT THERAPY:
- •No prior systemic therapies except for intravesical therapy for superficial disease
- •No prior sorafenib tosylate
- •No prior systemic chemotherapy
- •At least 4 weeks since prior investigational agents
排除标准
- 未提供
结局指标
主要结局
Pathological complete response
次要结局
- Safety and tolerability
- Potential biological correlates of disease response and drug activity in tumor tissue samples before and after therapy
- Correlation between 18FDG-PET and standard CT results
研究者
研究点 (2)
Loading locations...
相似试验
终止
2 期
Cisplatin, Bevacizumab, and Gemcitabine Followed by Surgery, Bevacizumab, and Paclitaxel in Treating Patients With Locally Advanced Nonmetastatic Bladder Cancer That Can Be Removed By SurgeryBladder CancerNCT00268450Medical University of South Carolina21
已完成
2 期
Cisplatin or Carboplatin Combined With Gemcitabine in Locally Advanced, Recurrent, or Metastatic Malignant Salivary Gland TumorHead and Neck CancerNCT00079079NCIC Clinical Trials Group34
已完成
2 期
Gemcitabine Hydrochloride, Cisplatin, and Sunitinib Malate as First-Line Therapy in Treating Patients With Locally Advanced And/or Metastatic Transitional Cell Carcinoma of the Urothelium (SUCCINCT)Transitional Cell Cancer of the Renal Pelvis and UreterUrethral CancerBladder CancerNCT01089088Cardiff University63
已完成
2 期
Gemcitabine, Cisplatin, and Dexamethasone in Treating Patients With Relapsed or Refractory Hodgkin's LymphomaLymphomaNCT00090909Jonsson Comprehensive Cancer Center1
撤回
2 期
Gemcitabine Hydrochloride and Carboplatin With or Without MK-0646 as First-Line Therapy in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung CancerLung CancerNCT00951444Alliance for Clinical Trials in Oncology