A Phase II Randomized Discontinuation Trial Of Carboxyaminoimidazole (CAI, NSC 609974) In Metastatic Renal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 335
- 试验地点
- 1
- 主要终点
- Proportion of patients progressing on placebo to the proportion progressing on CAI
研究概览
简要总结
Randomized phase II trial to study the effectiveness of carboxyamidotriazole in treating patients who have metastatic kidney cancer. Carboxyamidotriazole may stop the growth of kidney cancer by stopping blood flow to the tumor
详细描述
OBJECTIVES:
I. Determine the toxicity and disease-stabilizing effect of carboxyamidotriazole in patients with metastatic renal cell carcinoma.
II. Determine the objective response rate in patients treated with this drug.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to time from diagnosis of metastatic disease to study entry (fewer than 24 months vs 24 months or more).
Patients receive oral carboxyamidotriazole (CAI) daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed renal cell carcinoma
- •Metastatic or unresectable disease
- •Documented disease progression, even after nephrectomy
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques
- •At least 10 mm by spiral CT scan
- •The following lesions are not considered measurable:
- •Bone lesions
- •Leptomeningeal disease
- •Pleural/pericardial effusion
- •Abdominal masses not confirmed and followed by imaging
- •Cystic lesions
- •Performance status - CTC 0-2
- •WBC at least 2,000/mm^3
- •Platelet count at least 75,000/mm^3
- •Bilirubin no greater than upper limit of normal (ULN)
- •AST no greater than 2.5 times ULN
- •Creatinine no greater than 2.0 mg/dL
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No baseline neuropathy or cerebellar dysfunction greater than grade 1
- •At least 4 weeks since prior immunotherapy
- •No prior carboxyamidotriazole
- •No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)
- •Concurrent epoetin alfa allowed
- •At least 4 weeks since prior chemotherapy
- •No concurrent chemotherapy
- •No concurrent hormonal therapy except steroids for adrenal failure or hormones for conditions not related to disease (e.g., insulin for diabetes)
- •At least 4 weeks since prior radiotherapy
- •No concurrent palliative radiotherapy
- •See Disease Characteristics
- •At least 4 weeks since prior surgery
排除标准
- 未提供
研究组 & 干预措施
Arm I (carboxyaminoimidazole)
Patients receive oral CAI daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity.
Patients receive oral CAI as above.
干预措施: carboxyamidotriazole (Drug)
Arm II (carboxyamidotriazole, placebo)
Patients receive oral CAI daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity.
Patients receive a placebo.
干预措施: carboxyamidotriazole (Drug)
Arm II (carboxyamidotriazole, placebo)
Patients receive oral CAI daily for 4 weeks. Treatment repeats for 4 courses in the absence of disease progression or unacceptable toxicity. After 4 courses, patients experiencing complete or partial response continue treatment until disease progression or unacceptable toxicity.
Patients receive a placebo.
干预措施: placebo (Other)
结局指标
主要结局
Proportion of patients progressing on placebo to the proportion progressing on CAI
时间窗: Up to 16 weeks
Proportions of patients with stable disease
时间窗: Up to 16 weeks
Objective response
时间窗: Up to 16 weeks
次要结局
未报告次要终点