Phase II Trial of O6Benzylguanine and BCNU in Patients With Colon and Rectal Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.
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. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer.
详细描述
OBJECTIVES:
- Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.
- Evaluate tumor tissue biochemical and immunohistochemical predictors of response in patients treated with this regimen.
- Correlate carcinoembryonic antigen levels in the peripheral blood with response in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive O6-benzylguanine (BG) IV over 1 hour and carmustine IV over 1 hour (beginning 1 hour after completion of BG infusion) on day 1. Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of metastatic colorectal carcinoma
- •Bidimensionally measurable disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •At least 12 weeks
- •Hematopoietic:
- •WBC at least 4,000/mm^3
- •Granulocyte count at least 1,500/mm^3
- •Absolute neutrophil count at least 1,500/mm^3
- •Platelet count at least 100,000/mm^3
- •Hemoglobin greater than 8 g/dL
- •Bilirubin no greater than 1.2 mg/dL
- •AST and ALT less than 2.5 times upper limit of normal (ULN)
- •PT no greater than ULN (not on anticoagulation therapy)
- •Creatinine no greater than 1.5 mg/dL
- •Creatine clearance greater than 60 mL/min
- •DLCO at least 60%
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception during and for 2 months after study
- •No other concurrent active malignancies
- •Prior malignancies presumed to be cured allowed
- •No other concurrent uncontrolled severe medical problem that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •Not specified
- •Chemotherapy:
- •At least 6 months since prior adjuvant chemotherapy without disease recurrence
- •No more than 1 prior chemotherapy regimen for metastatic disease
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Prior adjuvant radiotherapy allowed
- •No prior radiotherapy to more than 25% of total bone marrow
- •Not specified
- •No other prior therapy for advanced disease
排除标准
- 未提供
结局指标
主要结局
Determine the response rate of patients with metastatic colorectal carcinoma treated with O6-benzylguanine and carmustine.
时间窗: Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity.
次要结局
未报告次要终点