EUCTR2008-006214-26-GB进行中（未招募）不适用
Phase II Trial of Neoadjuvent Cisplatin, Gemcitabine and Sunitinib Malate followed by radical cystectomy for transitional Cell Carcinoma (TCC) of the bladder
Hoosier Oncology Group0 个研究点目标入组 46 人开始时间: 2009年5月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Written informed consent for release of personal health information.
- •Age > 18 years at the time of consent.
- •ECOG Performance Status of 0-1 within 14 days prior to registration for protocol therapy.
- •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.
- •NOTE: Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- •Females must not be breastfeeding.
- •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.
- •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 prior radiotherapy to the pelvis.
- •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.
- •NOTE: Laboratory values must be obtained within 14 days prior to registration for protocol therapy.
- •Total bilirubin < 1.5 x Upper Limit of Normal (ULN)
- •Aspartate aminotransferase (AST) = 2.5 x ULN
- •Alanine aminotransferase (ALT ) = 2.5 x ULN
- •Calculated creatinine clearance of =60 cc/min as calculated with Cockroft-Gault equation.
- •Absolute Neutrophil Count (ANC) > 1.5 K/mm3 [International Sites (IS): 1.5 x 109/L].
- •Platelets > 100 K/mm3 [IS: 100 x 109/L].
- •Hemoglobin (Hgb) > 9.0 g/dL [IS: 90 g/L].
- •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 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Any prior malignancy 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 diseasefree
- •for at least 5 years.
- •Any surgical procedure less than 2 weeks prior to registration for protocol therapy.
- •Treatment with any investigational agent within 30 days prior to registration for protocol therapy.
- •Prior radiotherapy to the pelvis.
- •Clinically significant infections as judged by the treating investigator.
- •Evidence of NCI CTCAE Version 3.0 grade 3 hemorrhage within 28 days prior to registration for protocol therapy
- •(excluding resolved hematuria).
- •Uncontrolled angina, congestive heart failure or myocardial infarction or coronary/peripheral artery bypass graft within
- •6 months prior to registration for protocol therapy.
- •Cerebrovascular accident or transient ischemic attack within 6 months prior to registration for protocol therapy.
- •Evidence of pulmonary embolism within 6 months prior to registration for protocol therapy.
- •Uncontrolled hypertension (>150/100 mm Hg despite optimal medical therapy).
- •Evidence of ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade 2.
- •History of uncontrolled/untreated thyroid dysfunction.
- •Prolonged QTc interval (>450 msec) on preentry
- •electrocardiogram obtained within 28 days prior to registration for
- •protocol therapy.
- •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.
- •Use of CYP3A4 inhibitors within 7 days of registration for protocol therapy (ketoconazole, itraconazole, voriconazole,
- •fluconazole, troleandomycin, clarithromycin, erythromycin, diltiazem, verapamil, delavirdine, amprenavir, lopinivir,
- •indinavir, saquinavir, ritonavir, nelfinavir, nefazodone, fluvoxamine, cimetidine, aprepitant).
- •Use of CYP3A4 inducers within 14 days of registration for protocol therapy (rifampicin, rifabutin, rifapentine,
- •carbamazepine, phenobarbital, phenytoin, St John’s Wort, modafinil, efavirenz, nevirapine, cortisone (>50 mg),
- •hydrocortisone (>40mg), prednisone (>10 mg), methylprednisolone (>8 mg), dexamethasone (>1.5 mg)2).
- •Use of amiodarone (CYP3A4 inhibitor) within 6 months of registration for protocol therapy.
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