A Phase II Evaluation of Trastuzumab (MoAb HER2) in Patients With Advanced, Recurrent or Persistent Endometrial Carcinoma With or Without Prior Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Frequency and severity of observed adverse effects assessed using Common Terminology Criteria (CTC) version 2.0
研究概览
简要总结
Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage III, stage IV, or recurrent endometrial cancer.
详细描述
PRIMARY OOBJECTIVES:
I. Determine the antitumor activity of trastuzumab (Herceptin), in terms of response, in patients with advanced, recurrent, or persistent endometrial adenocarcinoma that demonstrates HER2/neu gene amplification by fluorescent in situ hybridization.
II. Determine the toxicity of this regimen in these patients.
SECONDARY OBJECTIVES:
I. Determine the progression-free and overall survival of patients treated with this regimen.
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
- •Histologically confirmed endometrial adenocarcinoma
- •Advanced, recurrent, or persistent disease
- •Refractory to curative therapy
- •HER2/neu gene amplification by fluorescent in situ hybridization
- •Measurable disease
- •Previously irradiated field as sole site of measurable disease allowed if evidence of progression since completion of radiotherapy
- •Performance status - GOG 0-2
- •Absolute neutrophil count ? 1,500/mm^3
- •Platelet count ? 100,000/mm^3
- •Bilirubin ? 1.5 times upper limit of normal (ULN)
- •Creatinine ? 1.5 times ULN
- •LVEF ? 45% by echocardiogram or MUGA
- •History of coronary artery disease and/or congestive heart failure allowed if medical management of condition has been stable within the past 6 months
- •No active or unstable cardiac disease
- •No active angina
- •No myocardial infarction within the past 6 months
- •No requirement for supplemental oxygen at rest or with ambulation
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No active infection requiring antibiotics
- •No uncontrolled infection
- •No other invasive malignancy within the past 5 years except nonmelanoma skin cancer
- •No other unstable medical condition that would preclude study participation
- •At least 3 weeks since prior biologic and immunologic agents directed at the malignant tumor
- •No prior anti-HER2 monoclonal antibody preparation
- •No other concurrent immunotherapy
- •Recovered from prior chemotherapy
- •Multiple prior chemotherapy regimens allowed
- •No more than 320 mg/m^2 total dose of prior doxorubicin allowed (including doxorubicin HCl liposome or other liposomally encapsulated doxorubicin preparations)
- •No concurrent chemotherapy
- •At least 1 week since prior hormonal therapy directed at the malignant tumor
- •No concurrent hormonal therapy
- •Continuation of hormone replacement therapy allowed
- •See Disease Characteristics
- •At least 3 weeks since prior radiotherapy for the malignant tumor and recovered
- •No concurrent radiotherapy
- •Recovered from prior recent surgery
- •At least 3 weeks since any prior therapy directed at the malignant tumor
- •No prior cancer treatment that would contraindicate study therapy
排除标准
- 未提供
研究组 & 干预措施
Treatment (trastuzumab)
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Trastuzumab (Biological)
Treatment (trastuzumab)
Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
结局指标
主要结局
Frequency and severity of observed adverse effects assessed using Common Terminology Criteria (CTC) version 2.0
时间窗: Up to 5 years
Frequency and duration of objective response
时间窗: Up to 5 years
次要结局
- Duration of progression-free survival(From study entry until disease progression, death or date or last contact, assessed up to 5 years)
- Prognostic factors (i.e., initial performance status and histological grade)(Not Provided)
- Duration of overall survival(From study entry to death or date or last contact, assessed up to 5 years)