NCT01589094已完成2 期
Phase II Study of Neoadjuvant Dose Dense Gemcitabine and Cisplatin (DD GC) In Patients With Muscle-Invasive Bladder Cancer
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
- 51
- 试验地点
- 8
- 主要终点
- Pathologic Response Rate
研究概览
简要总结
The purpose of this study is to find out if standard chemotherapy (gemcitabine and cisplatin) given on a dose-dense treatment schedule (with less time between treatments) can help shrink the tumor better than standard chemotherapy given on a standard treatment schedule before the patient undergoes surgery for bladder cancer.
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
- •Muscle invasive urothelial carcinoma of the bladder histologically confirmed at MSKCC or participating site ((Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or EUA.)
- •Clinical stage T2-T4a N0/X M0 disease
- •Medically appropriate candidate for radical cystectomy, as per MSKCC or participating site
- •Karnofsky Performance Status ≥ 70%
- •Age ≥ 18 years of age
- •Required Initial Laboratory Values:
- •Absolute Neutrophil Count ≥ 1000 cells/mm3
- •Platelets ≥ 100,000 cells/mm3
- •Hemoglobin ≥ 9.0g/dL
- •Bilirubin ≤ 1.5 the upper limit of normal (ULN) for the institution
- •Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 x ULN for the institution
- •Alkaline phosphatase ≤ 2.5 x ULN for the institution
- •Serum creatinine ≤ 1.5 mg/dL
- •Estimated glomerular filtration rate ≥ 60 ml/min/1.73m2 using the CKD-EPI equation: eGFR = 141 x min(Scr/k, 1)a x max(Scr/k, 1)-1.209 x 0.993Age
- •x 1.018 [if female] x 1.159 [if black] Scr is serum creatinine, k is 0.7 for females and 0.9 for males, a is -0.329 for females and -0.411 for males, min indicates the minimum of Scr/k or 1, and max indicates the maximum of Scr/k or 1
- •If female of childbearing potential, pregnancy test is negative
排除标准
- •Prior systemic chemotherapy (prior intravesical therapy is allowed)
- •Prior radiation therapy to the bladder
- •Evidence of NYHA functional class III or IV heart disease
- •Serious intercurrent medical or psychiatric illness, including serious active infection
- •Preexisting sensory grade ≥ 2 neuropathy
- •Preexisting grade ≥ 2 hearing loss
- •Major surgery or radiation therapy < 4 weeks of starting study treatment
- •Concomitant use of any other investigational drugs
- •Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack
- •Ongoing cardiac dysrhythmias of NCI CTCAE Version 4.0 grade ≥ 2
- •Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection
- •Concurrent treatment on another clinical trial; supportive care trials or non-treatment trials, e.g. QOL, are allowed
- •Pregnancy or breast-feeding. Patients must be surgically sterile, postmenopausal, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. Male patients must be surgically sterile or agree to use effective contraception.
研究组 & 干预措施
Gemcitabine and Cisplatin (DD GC)
Experimental
This is a Multicenter Phase II study of dose-dense (DD) gemcitabine and cisplatin (GC) neoadjuvant chemotherapy in patients with muscle-invasive bladder cancer (MIBC) who are candidates for radical cystectomy.
干预措施: Gemcitabine and Cisplatin (DD GC) (Drug)
结局指标
主要结局
Pathologic Response Rate
时间窗: 1 year
Defined as the absence of muscle invasive carcinoma (\<pT2 disease) and the absence of lymph node metastases (N0) on the final cystectomy specimen. Pathologists will assess surgical specimens systematically using criteria agreed upon for all conventional neoadjuvant treatment based on the AJCC TNM staging system.
次要结局
- Number of Participants With Toxicity(1 year)
- 2 Year Recurrence Free Survival (RFS) Rate for Responders(2 years)
- 2 Year Recurrence Free Survival (RFS) Rate for Nonresponders(2 years)
研究者
研究点 (8)
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