A Phase II Evaluation of Trastuzumab In Patients With HER2 Positive Persistent Or Recurrent Vulvar Paget's Disease
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- measurement of the longest diameter for all target lesions
研究概览
简要总结
This is a phase II open-label study of the activity and safety of trastuzumab in patients with vulvar Paget's disease with overexpression of HER2 on biopsy.
详细描述
The primary objective will be to estimate the anti-tumor activity of trastuzumab by evaluating the response to trastuzumab therapy in patients with recurrent or persistent vulvar Paget's disease demonstrating HER2/neu overexpression by immunohistochemistry and/ or FISH ((fluorescence in situ hybridization).
The secondary objectives:
- To evaluate the quality of life, based on the severity of the patients' vulvar itching on a 4-point verbal rating scale from 0 to 3 (0=no itching, 1=mild itching/ bothersome, 2=moderate itching/ troublesome, 3=severe itching/ extremely troublesome) as well as on the severity of the patients' vulvar pain on a numeric pain scale from 0-10 (0=no pain, 1-3=mild pain, 4-6=moderate pain, 7-10=severe pain).
- To assess the frequency and severity of observed adverse effects
- To assess the frequency/ incidence of HER2 in Paget's disease of the vulva
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
- Female
- 接受健康志愿者
- 否
入选标准
- •recurrent or persistent vulvar Paget's disease with overexpression of HER2 by immunohistochemistry and or fluorescence in situ hybridization (FISH)
- •Biopsy for histologic confirmation
- •Measurable disease
- •Karnofsky score of 50-100
- •recovered from effects of recent surgery, radiotherapy, or chemotherapy
- •free of active infection requiring antibiotics
- •adequate bone marrow function,renal function,hepatic function,cardiac function,WOCBP-neg.serum pregnancy,meet requirements in section 7.0
排除标准
- •no measurable disease
- •tumors not HER2 positive by immunohistochemistry FISH
- •prior therapy with any anti-HER2 monoclonal antibody preparation
- •Karnofsky score of 0-40
- •other invasive malignancies, with the exception of non-melanoma skin cancer
- •Patients requiring supplemental oxygen
- •unstable medical conditions in the opinion of the treating physician place them at unacceptably increased risk from trastuzumab therapy
- •Patients with active or unstable cardiac disease, or myocardial infarction within 6 months
研究组 & 干预措施
Trastuzumab
Open Label
干预措施: trastuzumab (Drug)
结局指标
主要结局
measurement of the longest diameter for all target lesions
时间窗: 5 years
Where possible measurement of the target lesion size in 2 perpendicular diameters will be required for follow up. A Change in the product of these 2 diameters affords some estimate of change in tumor size and hence therapeutic efficacy. Response criteria will be based on the RECIST modified response evaluation criteria (appendix I).The reporting of these changes will be on an individual case basis and will be in terms of the best response achieved by that case.
次要结局
- To assess the safety profile of trastuzumab in persistent or recurrent vulvar Paget's disease(5 years)