NCT00039429已完成2 期
A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 177
- 主要终点
- Progression-free survival at 6 months
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well atrasentan works in treating patients with locally recurrent or metastatic kidney cancer.
详细描述
OBJECTIVES:
- Determine the 6-month progression-free survival rate, in terms of proportion of those with measurable disease or bone metastases only, of patients with locally recurrent or metastatic renal cell carcinoma treated with atrasentan (measurable disease stratum closed to accrual as of 7/16/04).
- Determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study. Patients are stratified according to prior immunotherapy/biologic therapy (yes vs no) and characteristic of disease (measurable vs bone metastases only) (measurable disease stratum closed to accrual as of 7/16/04).
Patients receive oral atrasentan once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually for 5 years.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed locally recurrent or metastatic renal cell carcinoma that is not amenable to resection
- •Progressive disease, defined by 1 of the following:
- •The appearance of 1 or more new lesions
- •At least a 20% increase in the sum of the longest diameters of the target lesions (taking as a reference the smallest sum of the longest diameters recorded since the baseline measurements) (measurable disease stratum closed to accrual as of 7/16/04.)
- •One of the following disease characteristics:
- •Disease manifested solely by bone metastases
- •At least 1 measurable lesion (measurable disease stratum closed to accrual as of 7/16/04.)
- •At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
- •No prior or concurrent brain metastases
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •WBC at least 2,000/mm^3 OR
- •Absolute neutrophil count greater than 1,000/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin at least 9 g/dL
- •Bilirubin less than 1.5 mg/dL
- •AST and/or ALT less than 1.5 times upper limit of normal (ULN)
- •Creatinine less than 1.5 times ULN
- •Cardiovascular:
- •No history of New York Heart Association class II-IV heart disease
- •No significant pulmonary disease requiring pulse steroid therapy within the past 3 months
- •No other malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •No other serious concurrent medical illness that would preclude study participation
- •No active infection
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior biologic therapy/immunotherapy and recovered
- •No more than 1 prior regimen* of biologic therapy/immunotherapy (e.g., interleukin-2, interferon, thalidomide, or combination)
- •Prior sargramostim (GM-CSF) is not counted as prior biological therapy NOTE: *A regimen is considered to be at least 4 weeks of treatment
- •Chemotherapy:
- •No prior chemotherapy
- •Endocrine therapy:
- •At least 4 weeks since prior hormonal agents (e.g., megestrol or tamoxifen) and recovered
- •Radiotherapy:
- •At least 4 weeks since prior radiotherapy and recovered
- •Prior radiotherapy for local control or palliation of painful bony lesion allowed
- •No prior radiotherapy to target lesions
- •No concurrent radiotherapy for palliation or any other indication
- •At least 4 weeks since prior surgery and recovered
- •Prior nephrectomy allowed
- •Prior bisphosphonates allowed
排除标准
- 未提供
结局指标
主要结局
Progression-free survival at 6 months
Toxicity
次要结局
未报告次要终点
研究者
研究点 (177)
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