Randomized Phase II Evaluation of Carboplatin/Paclitaxel With and Without Trastuzumab (Herceptin) in HER2/Neu+ Patients With Advance/Recurrent Uterine Serous Papillary Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 20
- 主要终点
- Progression Free Survival Differences Between Treatment Arms.
研究概览
简要总结
The primary objective of this study is to estimate whether the addition of trastuzumab to paclitaxel and carboplatin chemotherapy improves progression free survival when compared to paclitaxel and carboplatin alone in Uterine Serous Papillary Carcinoma (USPC) patients overexpressing Her2/neu at 3+ level by immunohistochemistry (IHC)or positive by fluorescence in situ hybridization (FISH).
详细描述
The purpose of this study is to perform a randomized Phase II evaluation of Carboplatin/Paclitaxel with or without Trastuzumab (Herceptin) in patients with HER2/neu+ advanced stage/recurrent disease with an emphasis on determining the progression free survival in USPC patients and assessing immunologic markers predictive of trastuzumab response.
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
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must have advanced (stage III-IV) or recurrent histologically confirmed USPC with measurable disease.
- •Patients must harbor a tumor HER2/neu+ based upon IHC staining score of 3+ or 2+ with confirmed gene amplification by FISH
排除标准
- •Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancers, significant history of cardiac disease, uncontrolled hypertension, unstable medical issue, brain leptomeningeal, prior therapy with trastuzumab, uncontrolled seizure disorder, seropositive for HIV, active hepatitis, hemorrhagic diathesis or requiring supplemental oxygen.
研究组 & 干预措施
Carboplatin/Paclitaxel
Chemotherapy
干预措施: Carboplatin/Paclitaxel (Drug)
Trastuzumab
Monoclonal antibody
干预措施: Trastuzumab (Drug)
结局指标
主要结局
Progression Free Survival Differences Between Treatment Arms.
时间窗: 6 years
Progression free survival differences between treatment arms.
次要结局
- To Assess Objective Response Rate (ORR)(6 years)
- To Assess the Safety Profile of Trastuzumab in USPC Patients by CTCAE v4.0(6 years)
- To Assess Overall Survival (OS)(6 years)