Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach
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.
研究概览
详细说明
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.
OUTLINE: This is an open-label, multicenter study.
Patients receive epirubicin IV over 30 minutes and docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
研究类型
阶段
- 阶段2
联系人和位置
学习地点
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Angers、法国、49036
- Centre Paul Papin
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Argenteuil、法国、95107
- Centre Hospitalier Victor Dupouy
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Aulnay Sous Bois、法国、93602
- Centre Hospital General Robert Ballanger
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Beauvais、法国、60021
- C.H.G. Beauvais
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Bordeaux、法国、F-33000
- Clinique Tivoli
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Chartres、法国、28018
- Hôpital Louis Pasteur
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Dijon、法国、21000
- Hopital Drevon
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Hyeres、法国、83400
- Clinique Sainte-Marguerite
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Le Mans、法国、F-72000
- Clinique Victor Hugo
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Lille、法国、59037
- Centre Hospital Universitaire Hop Huriez
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Lyon、法国、69008
- Clinique Saint Jean
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Lyon、法国、69317
- Hôpital de la Croix Rousse
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Marseille、法国、13385
- CHU de la Timone
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Montfermeil、法国、93370
- Intercommunal Hospital
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Neuilly Sur Seine、法国、F-92202
- American Hospital of Paris
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Paris、法国、75970
- Hopital Tenon
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Paris、法国、75571
- Hopital Saint Antoine
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Paris、法国、75674
- Hopital Saint Joseph
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Pau、法国、64000
- Maison Medicale Marzet
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Pontoise、法国、95300
- Hôpital René Dubos
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Senlis、法国、60309
- C.H. Senlis
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Toulon、法国、83800
- Hopital d'Instruction des Armes Sainte-Anne
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Tours、法国、37044
- CHRU de Tours - Hôpital Trousseau
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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:
Age
- 18 to 75
Performance status
- ECOG 0-2
Life expectancy
- At least 3 months
Hematopoietic
- Absolute neutrophil count at least 2,000/mm^3
- Platelet count greater than 100,000/mm^3
Hepatic
- 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
Renal
- 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
Other
- 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
Surgery
- Not specified
Other
- More than 21 days since prior participation in another clinical study
- No other concurrent experimental medication
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 屏蔽:无(打开标签)
研究衡量的是什么?
主要结果指标
结果测量 |
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客观肿瘤缓解率
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肿瘤进展时间
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次要结果测量
结果测量 |
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总生存期
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耐受性
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Survival without local relapse
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合作者和调查者
调查人员
- Christophe Louvet, MD, PhD、Hopital Saint Antoine
研究记录日期
研究主要日期
学习开始
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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