NCT00075465Unknown2 期
Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach
GERCOR - Multidisciplinary Oncology Cooperative Group46 个研究点 分布在 1 个国家开始时间: 2001年4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
- 46
- 主要终点
- Objective tumor response rate
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as docetaxel and epirubicin, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with epirubicin as first-line therapy works in treating patients with locally advanced or metastatic adenocarcinoma (cancer) of the stomach.
详细描述
OBJECTIVES:
Primary
- Determine the objective tumor response rate and time to tumor progression in patients with locally advanced or metastatic adenocarcinoma of the stomach treated with docetaxel and epirubicin as first-line therapy.
Secondary
- Determine the survival without local relapse and overall survival of patients treated with this regimen.
- Determine the tolerance to this regimen in these patients.
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 adenocarcinoma of the stomach
- •Locally advanced or metastatic disease
- •Measurable disease
- •At least 1 unidimensionally measurable target lesion at least 2 cm in diameter
- •No known symptomatic brain metastases
- •No bone metastases
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Life expectancy
- •At least 3 months
- •Hematopoietic
- •Absolute neutrophil count at least 2,000/mm^3
- •Platelet count greater than 100,000/mm^3
- •Bilirubin less than 2 times normal
- •AST and ALT no greater than 2.5 times normal
- •Alkaline phosphatase no greater than 2.5 times normal
- •Creatinine less than 1.6 mg/dL OR
- •Creatinine clearance greater than 60 mL/min
- •Cardiovascular
- •No serious cardiac failure within the past 12 months
- •No myocardial infarction within the past 12 months
- •No cardiac insufficiency
- •No angina
- •Not pregnant or nursing
- •Fertile patients must use effective contraception
- •No uncontrolled serious infection
- •No significant brain or psychiatric disorders
- •No intolerance to cortisone or polysorbate 80
- •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 peripheral neuropathy greater than grade 2
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy
- •Not specified
- •Chemotherapy
- •No prior chemotherapy
- •Endocrine therapy
- •Not specified
- •Radiotherapy
- •Not specified
- •Not specified
- •More than 21 days since prior participation in another clinical study
- •No other concurrent experimental medication
排除标准
- 未提供
结局指标
主要结局
Objective tumor response rate
Time to tumor progression
次要结局
- Survival without local relapse
- Overall survival
- Tolerability
研究者
研究点 (46)
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