Phase II Study of SU5416 (NSC 696819) for Patients With Progressive Metastatic Renal Cancer Failing Prior Biologic Therapy or 5-Fluorouracil Containing Regimens
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Rate of progression-free events
研究概览
简要总结
Phase II trial to study the effectiveness of SU5416 in treating patients who have metastatic kidney cancer that has not responded to previous therapy with interleukin-2. SU5416 may stop the growth of kidney cancer by stopping blood flow to the tumor
详细描述
OBJECTIVES:
I. Determine the clinical activity of SU5416 in patients with progressive metastatic renal cancer failing prior biologic therapy or fluorouracil-containing regimens.
II. Determine the changes in tumor perfusion in patients treated with this regimen.
III. Determine the time to progression and survival in patients treated with this regimen.
OUTLINE:
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed metastatic renal cell carcinoma
- •Prior removal of primary tumors
- •Bidimensionally measurable disease
- •Bone-only disease is not considered measurable
- •Progressive disease following no more than 2 prior biologic therapy (e.g.,interleukin-2, interferon alfa, vaccine, or dendritic cell therapy) orfluorouracil-containing (single-agent or in combination therapy) regimens
- •No known history of CNS metastasis unless all of the following are true:
- •Previously treated
- •Neurologically stable
- •No requirement for IV steroids or anticonvulsants
- •No requirement for oral steroids and no evidence of active or residual CNS disease on CT scan or MRI
- •Negative brain scan (CT scan or MRI) required if neurologic signs or symptoms suggestive of CNS metastasis present
- •Performance status - Zubrod 0-2
- •At least 12 weeks
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin no greater than 1.5 mg/dL
- •SGPT no greater than 2.5 times upper limit of normal
- •PT and PTT normal
- •Fibrinogen normal
- •D-Dimer assay normal
- •Creatinine no greater than 1.5 mg/dL
- •Creatinine clearance at least 60 mL/min
- •See Surgery
- •No active congestive heart failure
- •No uncontrolled angina
- •No myocardial infarction or severe/unstable angina within the past 6 months
- •No uncontrolled hypertension
- •No uncompensated coronary artery disease on electrocardiogram or physical examination
- •No severe peripheral vascular disease
- •No deep vein or arterial thrombosis within the past 3 months
- •No pulmonary embolism within the past 3 months
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No concurrent serious infection
- •No overt psychosis, mental disability, or incompetence
- •No diabetes mellitus
- •No other prior malignancy within the past 5 years except curatively treated nonmelanoma skin cancer or carcinoma in situ of the cervix
- •No hypersensitivity or allergic reaction to paclitaxel
- •See Disease Characteristics
- •No other concurrent anti-cancer biologic therapy
- •See Disease Characteristics
- •No concurrent anti-cancer chemotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior radiotherapy and recovered
- •No sole indicator lesion within the previously irradiated port
- •No concurrent anti-cancer radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior major surgery and recovered
- •At least 1 year since prior bypass surgery for atherosclerotic coronary artery disease
- 另有 2 项未显示
排除标准
- 未提供
研究组 & 干预措施
Treatment (semaxanib)
Patients receive SU5416 IV over 1 hour twice weekly. Treatment continues every 6 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with CR receive an additional 6 months of therapy after achieving CR.
干预措施: semaxanib (Drug)
结局指标
主要结局
Rate of progression-free events
时间窗: 6 months
Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
Objective response rate
时间窗: Up to 3 years
Estimated with associated confidence intervals using standard methods such as chi-square and Fisher's exact tests.
次要结局
- Survival(Up to 3 years)
- Time to disease progression(Up to 3 years)
- Time to treatment failure(Up to 3 years)
- Duration of response(Up to 3 years)