NCT01071928撤回2 期
A Phase II Trial of Docetaxel Plus ASA404 as Second-Line Therapy in Patients With Advanced Urothelial Carcinoma: Hoosier Oncology Group GU09-144
Hoosier Cancer Research Network0 个研究点开始时间: 2010年6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
- 撤回
- 发起方
- 主要终点
- To determine the best overall response rate (as measured by RECIST version 1.1) of docetaxel + ASA404 as second line therapy in patients with advanced urothelial carcinoma.
研究概览
简要总结
The purpose of this study is to explore the safety and activity of docetaxel + ASA404 as second-line chemotherapy in patients with advanced urothelial carcinoma.
详细描述
OUTLINE: This is a multi-center study.
21 Day Cycle Treatment Regimen:
- Docetaxel IV 75 mg/m2 over approximately 60 minutes on Day 1
- ASA404 (given after Docetaxel) IV 1800 mg/m2 over approximately 20 minutes on Day 1
Treatment will continue until disease progression or intolerable treatment related adverse effects.
Karnofsky performance status of ≥ 70% within 7 days prior to registration for protocol therapy.
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 or cytological proof of transitional cell carcinoma (TCC) of the bladder, urethra, ureter, or renal pelvis (urothelial carcinoma). Histology may be mixed, but still requires a component of TCC.
- •Measurable disease according to RECIST (version 1.1) and obtained by imaging within 30 days prior to registration for protocol therapy. Note: Sites of measurable disease can not be within a previously irradiated site.
- •Written informed consent and HIPAA authorization for release of personal health information.
- •Age > 18 years at the time of consent.
- •Must have received only one prior chemotherapy regimen, which must have included one of the following chemotherapeutic agents: cisplatin, carboplatin, or gemcitabine. Note: Prior chemotherapy may have been administered in the perioperative (neoadjuvant/adjuvant) or advanced/metastatic setting. Patients may have received prior treatment with paclitaxel.
- •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 12 weeks after treatment discontinuation.
- •Females of childbearing potential must have a negative pregnancy test within 7 days prior to registration for protocol therapy.
- •Females must not be breastfeeding.
排除标准
- •No prior treatment with docetaxel.
- •No symptomatic brain metastases. Patients with neurological symptoms must undergo a head CT scan or brain MRI to exclude brain metastasis. NOTE: Patients with treated brain metastasis must be off steroids and have completed radiation at least 14 days 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 cancers for which the patient has been disease-free for at least 5 years
- •No treatment with any investigational agent or chemotherapeutic agent within 30 days prior to registration for protocol therapy.
- •No radiotherapy within 14 days prior to registration for protocol therapy. Patients must have recovered from all radiotherapy-related toxicities.
- •No major surgery within 30 days prior to registration for protocol therapy (major surgery is defined by the use of general anesthesia).
- •No minor surgery 14 days prior to registration for protocol therapy. NOTE: Insertion of a vascular access device is allowed.
- •No history of any medical condition resulting in ≥ CTC grade 2 dyspnea.
- •Patients without long QT syndrome
- •No history of labile hypertension or poor compliance with anti-hypertensive regimen NOTE: No patients with systolic BP >140 mm Hg and/or diastolic BP > 90 mm Hg while on medication for hypertension.
- •No presence of atrial tachyarrhythmia (e.g., atrial fibrillation, atrial flutter, multifocal atrial tachycardia, supraventricular tachycardia) if not effectively rate-controlled.
- •No history of a sustained ventricular tachycardia
- •No history of ventricular fibrillation or Torsades de Pointes
- •No right bundle branch block and left anterior or posterior hemiblock (bifascicular block)
- •No bradycardia defined as heart rate <50 beats per minute
- •No concomitant use of drugs with risk of causing Torsades de Pointes.
- •No concomitant use of drugs that are inducers and inhibitors of UGT1A9 and UGT2B7.
研究组 & 干预措施
Docetaxel and ASA404 in Combination
Experimental
干预措施: Docetaxel (Drug)
Docetaxel and ASA404 in Combination
Experimental
干预措施: ASA404 (Drug)
结局指标
主要结局
To determine the best overall response rate (as measured by RECIST version 1.1) of docetaxel + ASA404 as second line therapy in patients with advanced urothelial carcinoma.
时间窗: 12 months
次要结局
- To evaluate progression-free survival in patients with advanced urothelial carcinoma(12 months)
- To evaluate survival at 1 year from start of treatment in patients with advanced urothelial carcinoma treated with docetaxel + ASA404 as second line therapy(12 months)
- To evaluate the safety of docetaxel and ASA404 combination, as measured by the NCI Common Toxicity Criteria version 3.0(12 months)
研究者
Matthew Galsky
Principal Investigator
Hoosier Cancer Research Network
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