NCT00028015已完成2 期
A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 7
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: Phase II trial to study the effectiveness of sarCNU in treating patients who have recurrent or metastatic colorectal cancer.
详细描述
OBJECTIVES:
- Determine the efficacy of SarCNU in patients with recurrent or metastatic colorectal cancer.
- Determine the qualitative and quantitative toxicity of this drug in these patients.
- Determine the time to progression and survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral SarCNU on days 1, 5, and 9. Treatment repeats every 6 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) receive 2 additional courses beyond documentation of CR. Patients who achieve partial response (PR) receive 4 additional courses beyond documentation of PR.
Patients are followed at 4 weeks and then every 3 months thereafter.
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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed colorectal cancer
- •Locally recurrent or metastatic disease
- •Previously treated with 1 chemotherapy regimen for recurrent or metastatic disease
- •At least 1 unidimensionally measurable lesion
- •At least 20 mm by conventional techniques OR
- •At least 10 mm by spiral CT scan
- •No prior radiotherapy to indicator lesion (clear disease progression or new lesion within a prior radiation port is acceptable)
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Absolute granulocyte count at least 1,500/mm^3
- •Platelet count at least 120,000/mm^3
- •Bilirubin normal
- •AST and ALT no greater than 2.5 times upper limit of normal
- •Creatinine normal OR
- •Creatinine clearance at least 60 mL/min
- •Cardiovascular:
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •DLCO at least 80% predicted
- •FVC at least 80% predicted
- •No history of significant pulmonary disease
- •No concurrent symptomatic pulmonary disease (e.g., chronic obstructive pulmonary disorder, chronic asthma)
- •No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or curatively treated carcinoma in situ of the cervix
- •No other serious illness or medical condition that would preclude study
- •No ongoing or active uncontrolled infection
- •No history of significant neurologic or psychiatric disorder that would preclude study
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 3 months after study
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •At least 4 weeks since prior immunotherapy
- •No concurrent immunotherapy
- •Chemotherapy:
- •See Disease Characteristics
- •Prior adjuvant chemotherapy allowed
- •No prior nitrosoureas
- •No prior second-line chemotherapy for recurrent or metastatic disease
- •At least 4 weeks since prior chemotherapy
- •No other concurrent chemotherapy
- •Endocrine therapy:
- •No concurrent corticosteroids
- •Radiotherapy:
- •See Disease Characteristics
- 另有 9 项未显示
排除标准
- 未提供
研究者
研究点 (7)
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