NCT00075738Unknown2 期
Phase II Study Of 5FU-Irinotecan-Cisplatin As First-Line Treatment In Patients With Metastatic Carcinoma Of The Esophagus
GERCOR - Multidisciplinary Oncology Cooperative Group30 个研究点 分布在 1 个国家开始时间: 2003年10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
- Objective response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, irinotecan, leucovorin, and cisplatin, work in 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 combination chemotherapy as first-line therapy works in treating patients with metastatic esophageal cancer.
详细描述
OBJECTIVES:
Primary
- Determine the objective response rate in patients with metastatic esophageal cancer treated with fluorouracil, irinotecan, leucovorin calcium, and cisplatin as first-line therapy.
Secondary
- Determine the clinical benefit in patients treated with this regimen.
- Determine the tolerability of this regimen in these patients.
- Determine local relapse-free survival of patients treated with this regimen.
- Determine the overall survival of 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed esophageal cancer
- •Metastatic disease
- •At least 1 unidimensionally measurable metastatic lesion
- •At least 10 mm by spiral scanner OR 20 mm by sequential scanner
- •Outside the field of prior radiotherapy
- •No known symptomatic brain metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count ≥ 1,500/mm^3
- •Bilirubin ≤ 1.5 times normal
- •Alkaline phosphatase ≤ 3 times normal (5 times normal if liver metastases are present)
- •SGOT and SGPT ≤ 3 times normal
- •Creatinine ≤ 1.5 mg/dL
- •Cardiovascular
- •No myocardial infarction within the past 6 months
- •No uncontrolled angina
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No other prior malignancy except curatively treated basal cell skin cancer or carcinoma in situ of the cervix
- •No other illness or medical condition that would preclude study participation
- •No psychological, social, familial, or geographical condition that would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •More than 6 months since prior fluorouracil and/or cisplatin
- •No other prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •See Disease Characteristics
- •More than 6 weeks since prior radiotherapy
- •More than 4 weeks since prior surgery
- •No concurrent participation in another clinical study
排除标准
- 未提供
结局指标
主要结局
Objective response rate
次要结局
- Clinical benefit
- Tolerability
- Local relapse-free survival
- Overall survival
研究者
研究点 (30)
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