Randomized Phase II Trial of Cetuximab With and Without Weekly Paclitaxel in Patients With Previously Treated Advanced Urothelial Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Progression Free Survival
研究概览
简要总结
The purpose of this research study is to determine whether the investigational drug cetuximab, (Erbitux) alone or with paclitaxel (Taxol) can stabilize the growth of urothelial cancer.
详细描述
This research study is being done to find out if cetuximab, alone or with paclitaxel will slow the growth of urothelial cancers. Cetuximab is an antibody that blocks a protein called epidermal growth factor receptor (EGFR). EGFR sits on the outside of tumor cells and controls tumor cell growth. This agent has been looked at alone and with other chemotherapy drugs including paclitaxel. It has been found to be safe and can shrink other types of cancer.
This research study is also being done to find out if cetuximab, alone or with paclitaxel shrinks urothelial tumors. If it extends the time the tumors shrink. If it helps people live longer.
The purpose of this research study is to find out what effects (good and bad) these treatments have on you and your cancer. We do not know if you will benefit from this research study. It is possible that your condition will get better, but it is also possible that there will be no effect on your condition or that your condition will get worse. We can use what we learn from this research study to help other people with the same disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 carcinoma of the urothelium (bladder,renal pelvis, ureter)
- •Measurable disease by RECIST
- •Patients who received only one prior systemic non-taxane regimen for urothelial cancer. May have received this in the adjuvant or neoadjuvant setting or for advanced disease.
- •Signed IRB approved consent
- •Must have tissue available for EGFR assessment and additional correlative studies
- •ECOG PS 0-2
- •18 years of age or older
- •Not of child bearing potential or negative pregnancy test within 7 days of treatment
- •ANC greater than or equal to 1,500/ul
- •Platelets greater than or equal to 100,00/ul
- •Creatinine less than or equal to 2x institutional ULN or create. clearance greater than or equal to 30, bilirubin less than or equal to 1.5x ULN, AST&ALT less than or equal to 5x ULN
排除标准
- •Received more than one prior regimen for advanced disease
- •Prior radiation to more than 30% of marrow containing skeleton
- •Prior therapy that specifically and directly targets the EGFR pathway
- •Prior severe infusion reaction to a monoclonal antibody, pre-existing neuropathy greater than or equal to grade 2
- •Prior reaction to Cremophor EL
- •Known acute hepatitis B or C or known HIV
- •Active or uncontrolled infection
- •Significant history of uncontrolled cardiac disease
- •Any concurrent chemotherapy not indicated in this study; or
- •Any other investigational agents
研究组 & 干预措施
Cetuximab alone
Cetuximab 250mg/m2 IV weekly during each 28 day cycle. Arm A closed to accrual June 11, 2009 for lack of efficacy
干预措施: Cetuximab (Drug)
Cetuximab with Paclitaxel
Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
干预措施: Cetuximab (Drug)
Cetuximab with Paclitaxel
Paclitaxel 80 mg/m2 IV weekly for every 28 day cycle. Cetuximab 250mg/m2 IV weekly for every 28 day cycle.
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Progression Free Survival
时间窗: Measures by CT scans following each 2 cycles of treatment and about every 8 weeks after off treatment for disease progression. Follow up for survival until time of death.
次要结局
- Response Rate, Duration of Response, Time to Progression Will be Assessed With Radiographic Imaging(Measured by CT scans after every 2 cycles of treatment (about every 8 weeks))