NCT00238121已完成2 期
A Phase II Study of BAY 43-9006 in Advanced/Recurrent Uterine Carcinoma/Carcinosarcoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 7
- 主要终点
- Objective Overall Response Rate
研究概览
简要总结
Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. This phase II trial is studying how well sorafenib works in treating patients with advanced or recurrent uterine cancer.
详细描述
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with advanced or recurrent uterine cancer treated with sorafenib.
II. Determine the toxic effects of this drug in these patients.
SECONDARY OBJECTIVES:
I. Determine progression-free survival of patients treated with this drug.
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
- •No prior sorafenib
- •Histologically or cytologically confirmed uterine carcinoma or carcinosarcoma:
- •Advanced or recurrent disease
- •Not amenable to curative surgery or radiotherapy
- •Measurable disease:
- •At least 1 unidimensionally measurable lesion >= 20 mm by conventional techniques OR >= 10 mm by spiral CT scan
- •Tumor tissue block must be available
- •No known brain metastases
- •Performance status:
- •ECOG 0-2 OR
- •Karnofsky 60-100%
- •Hematopoietic:
- •Absolute neutrophil count >= 1,500/mm3
- •Platelet count >= 100,000/mm3
- •No bleeding diathesis
- •Bilirubin normal
- •AST and ALT =< 2.5 times upper limit of normal
- •Creatinine =< 1.5 mg/dL OR
- •Creatinine clearance >= 60 mL/min
- •Cardiovascular:
- •No uncontrolled hypertension, defined by 1 of the following:
- •Blood pressure > 150/100 mm Hg
- •Currently taking > 1 antihypertensive agent
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No other active malignancy
- •No history of allergic reactions attributed to compounds of similar chemical or biological composition to sorafenib
- •No ongoing or active infection
- •No psychiatric illness or social situation that would preclude study compliance
- •No swallowing dysfunction that would preclude study drug ingestion
- •No other uncontrolled illness
- •Prior biological response modifier therapy allowed
- •No prior antiangiogenesis therapy
- •No prior MAPK-signaling agents
- •No prior vascular endothelial growth factor receptor (VEGFR) inhibitors
- •No more than 1 prior chemotherapy regimen
- •More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
- •Prior hormonal therapy allowed
- •Prior radiotherapy allowed provided the only site of measurable disease was not located within the radiation port OR disease has progressed since completion of therapy
- •Recovered from all prior therapy
- •Concurrent warfarin allowed provided all of the following are true:
- •Patient is therapeutic on a stable warfarin dose
- •INR target range =< 3
- •Patient is monitored with weekly INR testing
- •No active bleeding or pathological condition that carries a high bleeding risk
- •No concurrent combination antiretroviral therapy for HIV-positive patients
- •No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin, carbamazepine, or phenobarbital)
- •No concurrent rifampin
- •No concurrent Hypericum perforatum (St. John's wort)
- 另有 3 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment
Experimental
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
干预措施: sorafenib tosylate (Drug)
结局指标
主要结局
Objective Overall Response Rate
时间窗: Up to 5 years
Response was defined using the Response Evaluation Criteria in Solid Tumors (RECIST, http://www.ncbi.nlm.nih.gov/pubmed/10655437#): Complete Response(CR), disappearance of all target lesions; Partial Response(PR), at least a 30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR)=CR+PR.
次要结局
- Overall Survival(Up to 5 years)
- Duration of Response(Up to 5 years)
- Progression Free Survival(Up to 5 years)
研究者
研究点 (7)
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