NCT00859339终止2 期
A Phase II Trial of Neoadjuvant Cisplatin, Gemcitabine and Sunitinib Malate Followed by Radical Cystectomy for Transitional Cell Carcinoma (TCC) of the Bladder: Hoosier Oncology Group GU07-123
Noah Hahn, M.D.5 个研究点 分布在 2 个国家目标入组 9 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 5
- 主要终点
- Pathological Complete Response (pCR) Rate.
研究概览
简要总结
This trial will investigate the activity of sunitinib combined with cisplatin and gemcitabine followed by radical cystectomy in patients with Transitional Cell Carcinoma (TCC) of the Bladder.
详细描述
OUTLINE: This is a multi-center study.
- Gemcitabine ( 1000 mg/m2) IV days 1 and 8
- Cisplatin (70 mg/m2) IV day 1 and
- Sunitinib malate (37.5 mg) oral daily for days 1-14
The treatment regimen will be administered in four, 21-day, cycles followed by radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate.
ECOG performance status 0 or 1
Hematopoietic:
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
- •Histological proof of muscle-invasive transitional cell carcinoma of the bladder (stage II-III) with no evidence of metastatic disease (focal squamous and/or adenocarcinoma differentiation allowed, sarcomatoid and small-cell components not allowed). Patient with any degree of fixation of the pelvic sidewall are not eligible.
- •Must be willing to undergo a cystoscopy if tumor block is not available prior to registration for protocol therapy.
- •Eligible for radical cystectomy as per the attending urologist.
- •Prior radiation therapy to bone marrow is allowed to < 25% of the marrow, and must be completed at least 6 months prior to registration for protocol therapy
- •Written informed consent and HIPAA authorization for release of personal health information.
- •Age > 18 years at the time of consent.
- •Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) from the time consent is signed until 6 weeks after treatment discontinuation.
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy.
排除标准
- •No prior radiotherapy to the pelvis.
- •No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, Gleason< grade 7 prostate cancers, or other cancer for which the patient has been disease-free for at least 5 years.
- •No treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- •No cerebrovascular accident or transient ischemic attack within 6 months prior to registration for protocol therapy.
- •No evidence of pulmonary embolism within 6 months prior to registration for protocol therapy.
- •No uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy).
- •No evidence of ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade
- •No history of uncontrolled/untreated thyroid dysfunction.
- •No prolonged QTc interval (> 450 msec) on pre-entry electrocardiogram obtained within 28 days prior to being registered on study.
- •Patients on warfarin (>2mg) for thrombosis must be able and willing to switch to low molecular weight heparin prior to registration for protocol therapy.
- •No use of drugs having proarrhythmic potential (terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide and flecainide) within 7 days prior to registration for protocol therapy.
- •No use of CYP3A4 inhibitors (see section 5.3 for a list) within 7 days of registration for protocol therapy.
- •No use of CYP3A4 inducers (see section 5.3 for a list) within 14 days of registration for protocol therapy.
- •No use of amiodarone (CYP3A4 inhibitor) within 6 months of registration for protocol therapy.
- •Females must not be breastfeeding.
研究组 & 干预措施
Experimental Treatment
Experimental
Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
干预措施: Gemcitabine (Drug)
Experimental Treatment
Experimental
Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
干预措施: Cisplatin (Drug)
Experimental Treatment
Experimental
Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
干预措施: Sunitinib Malate (Drug)
Experimental Treatment
Experimental
Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy
干预措施: Radical Cystectomy (Procedure)
结局指标
主要结局
Pathological Complete Response (pCR) Rate.
时间窗: 18 months
number of participants with a pCR
次要结局
- Safety Profile(18 months)
- Objective Response Rate(18 months)
- Progression Free Survival(18 months)
- Correlate Biomarker Expression(18 months)
研究者
Noah Hahn, M.D.
Sponsor-Investigator
Hoosier Cancer Research Network
研究点 (5)
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