NCT01108055已完成2 期
A Phase II Study of Pazopanib in Combination With Weekly Paclitaxel in Refractory Urothelial Cancer
Sandy Srinivas2 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2010年4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
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Objective Tumor Response
研究概览
简要总结
We will combine an oral investigational vascular endothelial growth factor (VEGF inhibitor) called pazopanib which is being studied in kidney cancer will be combined with standard chemotherapy called taxol in patients with relapsed recurrent urothelial cancer.
详细描述
Based on the results from the Phase 1 study of pazopanib combined with paclitaxel and the activity of paclitaxel in urothelial cancer, testing this regimen in a disease where there is an unmet need appears appropriate.
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
- •Histologically confirmed transitional cell carcinoma (TCC) of the urothelium (bladder, renal pelvis, ureter, or urethra). Mixed histology is allowed as long as the predominant histology is TCC
- •First recurrence after treatment with a maximum of two chemotherapeutic regimens.
- •Subjects must provide written informed consent prior to performance of study-specific procedures or assessments, and must be willing to comply with treatment and follow up.
- •Procedures conducted as part of the subject's routine clinical management (eg, blood count, imaging study) and obtained prior to signing of informed consent may be utilized for screening or baseline purposes provided these procedures are conducted as specified in the protocol.
- •Age ≥ 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- •Measurable disease criteria by RECIST criteria
- •Adequate organ system function as defined below
- •Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L
- •Hemoglobin ≥ 9 g/dL
- •Platelets ≥ 100 X 10^9/L
- •Prothrombin time (PT) or international normalized ratio (INR) ≤ 1.2 x upper limit of normal (ULN)
- •Total bilirubin ≤ 1.5 x ULN
- •aspartate aminotransferase (AST) and Alanine Aminotransferase (ALT)≤ 2.5 x ULN
- •Serum creatinine ≤ 1.8 mg/dL
- •Urine Protein to Creatinine Ratio (UPC) < 1
- •A female is eligible to enter and participate in this study if she is of non-childbearing potential (ie, physiologically incapable of becoming pregnant). This includes any female who has had:
- •A hysterectomy
- •A bilateral oophorectomy (ovariectomy)
- •A bilateral tubal ligation
- •Menopause
- •Childbearing potential females must have a negative serum pregnancy test within 2 weeks prior to the first dose of study treatment, preferably as close to the first dose as possible, and agree to use adequate contraception. Adequate acceptable contraceptive methods, when used consistently and in accordance with both the product label and the instructions of the physician, are as follow:
- •An intrauterine device with a documented failure rate of less than 1% per year.
- •Vasectomized partner who is sterile prior to the female subject's entry and is the sole sexual partner for that female.
- •Complete abstinence from sexual intercourse for 14 days before exposure to investigational product, through the dosing period, and for at least 21 days after the last dose of investigational product.
- •Double-barrier contraception (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide).
排除标准
- •History of other malignancies within 5 years prior to Day 1 except for tumors with a negligible risk for metastasis or death, such as adequately controlled basal cell carcinoma, squamous-cell carcinoma of the skin, carcinoma in situ of the cervix, early-stage bladder cancer, or low-grade endometrial cancer Malignancies that have undergone a putative surgical cure (ie, localized prostate cancer post-prostatectomy) within 5 years prior to Day 1 may be discussed with the Medical Monitor
- •History or clinical evidence of central nervous system (CNS) metastases or leptomeningeal carcinomatosis, except for individuals who have previously-treated CNS metastases, are asymptomatic, and have had no requirement for steroids or anti-seizure medication for 6 months prior to first dose of study drug.
- •Clinically significant gastrointestinal abnormalities that may increase the risk for GI bleeding
- •Clinically significant gastrointestinal abnormalities that may affect absorption of the investigational product
- •Presence of uncontrolled infection.
- •Prolongation of corrected QT interval (QTc) > 480 milliseconds. On antiarrhythmics or medications known to prolong QT interval
- •History of any one or more of the following cardiovascular conditions within the past 6 months:
- •Cardiac angioplasty or stenting
- •Myocardial infarction
- •Unstable angina
- •Coronary artery by-pass graft surgery
- •Symptomatic peripheral vascular disease
- •Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
- •Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥ 140 mmHg or diastolic blood pressure (DBP) of ≥ 90mm Hg].
- •History of cerebrovascular accident, hemoptysis, cerebral hemorrhage, clinically significant GI bleed, pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months
- •Prior major surgery or trauma within 28 days prior to first dose of study drug and/or presence of any non-healing wound, fracture
- •Evidence of active bleeding or bleeding diathesis.
- •Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to procedures.
- •Patients on strong CYP3A4 inhibitors
- •Uncorrected abnormal electrolytes: K, Mg and Ca
- •Prior treatment with taxane chemotherapy
- •Treatment with any of the following anti-cancer therapies:
- •radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
- •chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
研究组 & 干预措施
pazopanib + paclitaxel
Experimental
Cycle of 28 days. Pazopanib: 800mg daily
Cycle of 28 days Paclitaxel: 80mg/m2 on days 1,8 and 15
干预措施: Pazopanib (GW786034) (Drug)
pazopanib + paclitaxel
Experimental
Cycle of 28 days. Pazopanib: 800mg daily
Cycle of 28 days Paclitaxel: 80mg/m2 on days 1,8 and 15
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Objective Tumor Response
时间窗: Every 8 weeks
The tumor response rate was assessed per the Response Evaluation Criteria In Solid Tumors (RECIST). RECIST criteria are a set of published rules that define when cancer patients improve ("respond"); stay the same ("stable"); or worsen ("progression") during treatments. RECIST criteria offer a simplified and conservative extraction of imaging data suitable for wide application in clinical trials. The criteria presume that linear measures are an adequate substitute for 2-dimensional (2D) methods and includes 4 response categories: * Complete response (CR) = Disappearance of all target lesions * Partial response (PR) = 30% decrease in the sum of the longest diameter of target lesions * Progressive disease (PD) = 20% increase in the sum of the longest diameter of target lesions * Stable disease (SD) = Small changes that do not meet above criteria Objective tumor response means those with response better than stable disease, ie, complete response (CR) + partial response (PR).
次要结局
- Progression-free Survival (PFS)(4 years)
- Overall Survival(4 years)
- Overall Response Rate(4 years)
- Median Overall Survival (OS) by Bellmunt Score(4 years)
研究者
Sandy Srinivas
Associate Professor of Medicine
Stanford University
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Pazopanib and ARQ 197 for Advanced Solid TumorsSolid TumorNCT01468922National Cancer Institute (NCI)32
已完成
2 期
Pazopanib in Treating Patients With Metastatic Urothelial CancerDistal Urethral CancerProximal Urethral CancerRecurrent Bladder CancerRecurrent Transitional Cell Cancer of the Renal Pelvis and UreterRecurrent Urethral CancerStage IV Bladder CancerTransitional Cell Carcinoma of the BladderUrethral Cancer Associated With Invasive Bladder CancerNCT00471536National Cancer Institute (NCI)19
进行中（未招募）
1 期
Pazopanib Pediatric Phase II Trial Children's Oncology Group in Solid TumorsRhabdomyosarcoma, non-rhabdomyosarcomatous soft tissue sarcoma (including synovial sarcoma, alveolar soft part sarcoma and desmoplastic small round cell tumor), Ewing sarcoma/peripheral Primitive Neuro Ectodermal Tumor (PNET), hepatoblastoma, neuroblastoma (measurable and evaluable), and osteosarcomaMedDRA version: 20.0 Level: HLT Classification code 10019825 Term: Hepatoblastomas System Organ Class: 100000005101MedDRA version: 20.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas System Organ Class: 100000004864MedDRA version: 20.0 Level: PT Classification code 10031291 Term: Osteosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: HLT Classification code 10039023 Term: Rhabdomyosarcomas System Organ Class: 100000143528MedDRA version: 20.0 Level: PT Classification code 10015560 Term: Ewing's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003595-12-CZovartis Pharma Services AG154
进行中（未招募）
1 期
Pazopanib Pediatric Phase II Trial Children's Oncology Group in Solid TumorsRhabdomyosarcoma, non-rhabdomyosarcomatous soft tissue sarcoma (including synovial sarcoma, alveolar soft part sarcoma and desmoplastic small round cell tumor), Ewing sarcoma/peripheral Primitive Neuro Ectodermal Tumor (PNET), hepatoblastoma, neuroblastoma (measurable and evaluable), and osteosarcomaMedDRA version: 20.0 Level: HLT Classification code 10019825 Term: Hepatoblastomas System Organ Class: 100000005101MedDRA version: 20.0 Level: PT Classification code 10029260 Term: Neuroblastoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas System Organ Class: 100000004864MedDRA version: 20.0 Level: PT Classification code 10031291 Term: Osteosarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: HLT Classification code 10039023 Term: Rhabdomyosarcomas System Organ Class: 100000143528MedDRA version: 20.0 Level: PT Classification code 10015560 Term: Ewing's sarcoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003595-12-ESovartis Farmacéutica, S.A.154
进行中（未招募）
1 期
Pazopanib Pediatric Phase II Trial Children's Oncology Group in Solid TumorsRhabdomyosarcoma, non-rhabdomyosarcomatous soft tissue sarcoma (including synovial sarcoma, alveolar soft part sarcoma and desmoplastic small round cell tumor), Ewing sarcoma/peripheral Primitive Neuro Ectodermal Tumor (PNET), hepatoblastoma, neuroblastoma (measurable and evaluable), and osteosarcomaMedDRA version: 20.0Level: HLTClassification code 10019825Term: HepatoblastomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10029260Term: NeuroblastomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 15.1Level: HLGTClassification code 10041299Term: Soft tissue sarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10031291Term: OsteosarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: HLTClassification code 10039023Term: RhabdomyosarcomasSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: PTClassification code 10015560Term: Ewing's sarcomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2013-003595-12-FRovartis Pharma Services AG154