NCT00081627已完成2 期
COFU: A Multi-Center Phase II Clinical Trial to Evaluate the Safety and Efficacy of Weekly Treatment With CoFactor and 5-Fluorouracil in Patients With Metastatic Colorectal Carcinoma
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 18
研究概览
简要总结
The objectives of this trial are to determine if CoFactor in combination with 5-FU are effective in the treatment of metastatic colorectal cancer and to determine the side effects observed with the administration of CoFactor and 5-FU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Patients must have surgically incurable colon or rectal adenocarcinoma
- •Karnofsky Performance Status of 60% or greater
- •Patients may have symptomatic neuropathy
- •Patients must have a life expectancy of at least 4 months
- •Patients must be alimenting, receiving at least 1500Kcal/day nutrition, by any route
- •Patients must have bidimensional measurable disease for response assessment
- •Patients may have received adjuvant chemotherapy with fluoropyrimidine therapy
- •Patients must have recovered from the toxicities of prior therapy, at least 4 weeks since prior adjuvant chemotherapy and major surgery
- •Serum creatinine less than 2.4mg%, serum bilirubin less than 3.0mg%, WBC greater than 3,200/mm2, AGC greater than 1,500/mm3, platelet count greater than 90,000/mm3 and SGOT (AST) and SGPT (ALT) less than 3 times the upper limit of normal
- •Male and non-pregnant, non-lactating female patients must be >18 years old.
排除标准
- •Concurrent infection
- •Failure of the patient or the patient's legal representative to sign the Informed consent
- •Inability to obtain Informed Consent because of psychiatric or complex medical problem
- •Patients with unstable oncologic emergency
- •Patients with unstable medical conditions such as angina, transient ischemic attacks, rising creatinine, accelerated hypertension, etc.
- •Cerebellar neurologic syndromes such as Parkinson's Disease, multiple sclerosis and amyotonia
- •Known intolerance to fluoropyrimidine therapy suggestive of dihydropyrimidine dehydrogenase deficiency.
研究者
研究点 (18)
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