NCT00075595Unknown2 期
Phase II Study of 5FU/Folinic Acid and Irinotecan as Second or Third Line Treatment in Patients With Metastatic, Unresectable, Colorectal Cancer
GERCOR - Multidisciplinary Oncology Cooperative Group30 个研究点 分布在 1 个国家开始时间: 2002年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 试验地点
- 30
- 主要终点
- Time to progression
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, and irinotecan, use different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one chemotherapy drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil together with leucovorin and irinotecan works in treating patients with recurrent or refractory metastatic unresectable colorectal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the time to progression and time to death from progression in patients with recurrent or refractory metastatic unresectable colorectal cancer treated with fluorouracil, leucovorin calcium, and irinotecan.
Secondary
- Determine the objective response and stabilization rate in patients treated with this regimen.
- Determine the time to treatment failure in patients treated with this regimen.
- Determine the duration of response in patients treated with this regimen.
- Determine overall survival rate in patients treated with this regimen.
- Determine the incidence of grade 3 or 4 toxicity in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed colorectal adenocarcinoma
- •Metastatic, unresectable disease
- •Meets 1 of the following criteria:
- •At least 1 unidimensionally measurable metastatic lesion at least 10 mm by spiral scan OR 20 mm by conventional scan
- •Evaluable disease
- •Evidence of disease (e.g., ascites or bone metastases) by imaging techniques
- •Progressive disease as defined by 1 of the following criteria:
- •Progressive disease while receiving first-line chemotherapy
- •Recurrent disease within 6 months after completing adjuvant chemotherapy
- •No symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Platelet count ≥ 100,000/mm^3
- •Bilirubin < 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase < 3 times ULN
- •Not specified
- •Cardiovascular
- •No uncontrolled angina
- •No myocardial infarction within the past 6 months
- •Gastrointestinal
- •No chronic diarrhea grade 2 or greater
- •No unresolved fully or partially obstructed intestine
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other underlying disease or medical condition that would preclude study participation
- •No other prior malignancy except curatively treated basal cell cancer or carcinoma in situ of the cervix
- •No psychological, social, familial, or geographical condition that would preclude study follow-up
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •See Disease Characteristics
- •No prior irinotecan
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •At least 3 weeks since prior radiotherapy
- •At least 3 weeks since prior surgery
- •No other concurrent clinical trial participation
排除标准
- 未提供
结局指标
主要结局
Time to progression
Time to death from progression
次要结局
- Objective response
- Stabilization rate
- Time to treatment failure
- Duration of response
- Overall survival rate
- Incidence of grade 3 or 4 toxicity
研究者
研究点 (30)
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