NCT00461851已完成2 期
A Phase II, Multicenter Trial of Gemcitabine, Carboplatin, and Sorafenib in Chemotherapy-naive Patients With Advanced/Metastatic Bladder Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This is a Phase II, nonrandomized multicenter study designed to evaluate time to progression and response proportion of patients with advanced or metastatic transitional cell carcinoma of bladder receiving 6 cycles of gemcitabine, carboplatin and sorafenib and then maintenance 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
- •Histologic documentation of diagnosis of transitional cell carcinoma of the bladder, urethra, ureter, or renal pelvis
- •Unresectable, locally advanced or metastatic disease
- •CrCl ≥ 60 ml/min or serum creatinine < 1.5
- •≥ 4 weeks since prior RT
- •ECOG Performance Status of 0 or 1 (Appendix I)
- •Age ≥ 18 years of age
- •Women of childbearing potential and men must agree to use adequate contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men and women should use adequate birth control for at least 2 weeks after the last administration of sorafenib.
- •Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
- •Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
- •Adequate bone marrow, liver and renal function as assessed by the following:
- •Hemoglobin > 9.0 g/dl
- •Absolute neutrophil count (ANC) ≥ 1,500/mm3
- •Platelet count ≥ 100,000/mm3
- •Total bilirubin ≤ 1.5 times ULN
- •ALT and AST ≤ 2.5 times the ULN ( ≤ 5 x ULN for patients with liver involvement)
- •INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.
排除标准
- •Prior treatment with systemic chemotherapy (prior intravesical chemotherapy is permitted, and adjuvant therapy is permitted if > 12 months have lapsed)
- •Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study
- •Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
- •History of stroke within six months
- •Clinically significant peripheral vascular disease
- •Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
- •Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
- •Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure > 90 mmHg, despite optimal medical management.
- •Sorafenib is contraindicated in patients with known severe hypersensitivity to sorafenib or any of the excipients.
- •Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
- •Active clinically serious infection > CTCAE Grade
- •Thrombolytic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
- •Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug
- •Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug
- •Evidence or history of bleeding diathesis or coagulopathy
- •Major surgery, significant traumatic injury within 4 weeks of first study drug
- •Use of St. John's Wort or rifampin (rifampicin)
- •Known or suspected allergy to sorafenib or any agent given in the course of this trial
- •Any condition that impairs patient's ability to swallow whole pills
- •Any malabsorption problem
- •Anticipation of need for major surgical procedure during the course of the study
- •Pregnant (positive pregnancy test) or lactating
- •History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
- •Serious, non-healing wound, ulcer, or bone fracture
- •Inability to comply with study and/or follow-up procedures
- •History of persistent gross hematuria
研究组 & 干预措施
Chemotherapy plus sorafenib
Experimental
Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone
干预措施: Gemcitabine (Drug)
Chemotherapy plus sorafenib
Experimental
Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone
干预措施: Carboplatin (Drug)
Chemotherapy plus sorafenib
Experimental
Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone
干预措施: Sorafenib (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Upon completion of study
The primary outcome was the proportion of patients who achieved progression free survival (PFS) of five months. PFS was defined as time to progression or any-cause mortality, whichever came first.
次要结局
- Dose Ruction (Toxicity)(Upon completion of study)
- Best Reported Response(Upon completion of study)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
A Study of Locally Advanced Pancreatic CancerLocally Advanced Pancreatic CancerNCT01063192National Health Research Institutes, Taiwan73
已完成
2 期
Efficacy of Combination of Trastuzumab to Gemcitabine - Platinum Advanced or Metastatic Urothelial CarcinomaRecurrent Bladder CancerStage IV Bladder CancerTransitional Cell Carcinoma of the BladderNCT01828736Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie61
撤回
2 期
A Study of Gemcitabine-Carboplatin Plus Necitumumab (LY3012211) in Chemotherapy-Naïve Participants With Locally Advanced or Metastatic Squamous Non-Small Cell Lung Cancer (NSCLC)Locally Advanced Squamous Non-Small Cell Lung CancerMetastatic Squamous Non-Small Cell Lung CancerNCT02941601Eli Lilly and Company
已完成
2 期
Induction Gemcitabine & Carboplatin Followed by Paclitaxel & Carboplatin +XRT in NSCLCLung CancerNCT00226590H. Lee Moffitt Cancer Center and Research Institute39
已完成
2 期
A Study to Determine Best Tumor Response With Trastuzumab Emtansine in Human Epidermal Growth Factor Receptor 2 (HER2) Overexpressing Solid TumorsPancreas CancerCholangiocellular CarcinomaBladder CancerNCT02999672Hoffmann-La Roche20