SarCNU in Treating Patients With Recurrent or Metastatic Colorectal Cancer
A Phase II Study of Second-Line SarCNU (NSC 364432) in Patients With Recurrent/Metastatic Colorectal Cancer
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.
研究概览
详细说明
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.
PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study within 6-8 months.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Manitoba
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Winnipeg、Manitoba、加拿大、R3E 0V9
- CancerCare Manitoba
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Ontario
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Kingston、Ontario、加拿大、K7L 5P9
- Kingston Regional Cancer Centre
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Ottawa、Ontario、加拿大、K1H 1C4
- Ottawa Regional Cancer Centre
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Toronto、Ontario、加拿大、M5G 2C4
- Toronto General Hospital
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Toronto、Ontario、加拿大、M5G 2M9
- Princess Margaret Hospital
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Quebec
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Montreal、Quebec、加拿大、H2W 1S6
- McGill University
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Montreal、Quebec、加拿大、H2L 4MI
- Hopital Notre- Dame du CHUM
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Absolute granulocyte count at least 1,500/mm^3
- Platelet count at least 120,000/mm^3
Hepatic:
- Bilirubin normal
- AST and ALT no greater than 2.5 times upper limit of normal
Renal:
- Creatinine normal OR
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No symptomatic congestive heart failure
- No unstable angina pectoris
- No cardiac arrhythmia
Pulmonary:
- 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)
Other:
- 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
- Prior radiotherapy as part of primary therapy allowed
- At least 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- Prior surgery as part of primary therapy allowed
- Prior reoperation for recurrent disease allowed
- At least 2 weeks since prior surgery other than biopsy
Other:
- At least 4 weeks since prior investigational agent
- No other concurrent investigational agents or therapy
- No other concurrent anticancer therapy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
合作者和调查者
调查人员
- 学习椅:Ralph PW Wong, MD, FRCPC、CancerCare Manitoba
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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