Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Essai Randomise Comparant Deux Stategies De Chimiotherapie Dans Les Cancers Pancreatiques Avances: LV5FU2 Simplifie + Cisplatine Suivi de Gemcitabine, Versus Gemcitabine Suivi de LV5FU2 Simplifie + Cisplatine en Can de Progression
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.
研究概览
详细说明
OBJECTIVES:
Primary
- Compare the overall survival of patients with unresectable metastatic pancreatic cancer treated with fluorouracil, leucovorin calcium, and cisplatin followed by gemcitabine hydrochloride vs gemcitabine hydrochloride followed by fluorouracil, leucovorin calcium, and cisplatin.
Secondary
- Compare progression-free survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the percentage of these patients needing second-line therapy.
- Compare the duration of hospitalization of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2), participating center, location of the tumor (ampullar region vs other locations), and infusion rate of gemcitabine hydrochloride (30 vs 100 minutes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive leucovorin calcium IV over 2 hours on day 1, cisplatin IV over 1 hour on day 1 or 2, and fluorouracil IV over 46 hours on day 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression also receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks. Patients then receive gemcitabine hydrochloride IV on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression receive fluorouracil, leucovorin calcium, and cisplatin as in arm I.
Quality of life is assessed at baseline and then every 2 months.
After completion of study therapy, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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Abbeville、法国、80101
- Centre Hospitalier d'Abbeville
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Avignon、法国、84902
- Hopital Duffaut
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Blois、法国、41016
- Centre Hospitalier de Blois
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Boulogne、法国、F-92104
- Centre Hospitalier Universitaire Ambroise Pare - Boulogne
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Boulogne Sur Mer、法国、62200
- Centre Hospitalier Docteur Duchenne
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Bourg En Bresse、法国、01012
- C.H. Bourg En Bresse
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Bourgoin-Jallieu、法国、38300
- Centre hospitalier Pierre Oudot
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Caen、法国、14076
- Centre Hospitalier Universitaire d'Amiens
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Chalons-en-Champagne、法国、51000
- Centre Hospitalier de Chalons-en-Champagne
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Clermont-Ferrand、法国、63003
- CHR Clermont Ferrand, Hotel Dieu
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Clichy、法国、92118
- Hôpital Beaujon
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Colmar、法国、68024
- Hôpital Louis Pasteur
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Dijon、法国、21034
- Hopital Du Bocage
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Dijon、法国、21079
- Centre de Lutte Contre le Cancer Georges-Francois Leclerc
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Draguignan、法国、83300
- Centre Hospitalier Draguignan
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Dunkerque、法国、59240
- Centre Hospitalier De Dunkerque - CHD
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Elbeuf、法国、76503
- Centre Hospitalier Intercommunal St. Aubin les Elbeuf
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Grenoble、法国、38043
- CHU de Grenoble - Hopital de la Tronche
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Guilherand Granges、法国、07500
- Clinique Pasteur
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Libourne、法国、33500
- Hôpital Robert Boulin
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Lille、法国、59037
- Centre Hospital Universitaire Hop Huriez
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Lille、法国、59037
- Centre Hospitalier Regional et Universitaire de Lille
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Lyon、法国、69437
- Hôpital Edouard Herriot
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Marseille、法国、13385
- CHU de la Timone
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Marseille、法国、13915
- CHU Nord
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Marseille、法国、13008
- Hôpital Saint Joseph
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Martigues、法国、13698
- Centre Hospitalier de Martigues
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Mont-de-Marsan、法国、40000
- Centre Hospitalier General de Mont de Marsan
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Montpellier、法国、34298
- Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
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Nantes、法国、44093
- CHR Hotel Dieu
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Orleans、法国、45100
- CHR D'Orleans - Hopital de la Source
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Paris、法国、75015
- Hôpital européen Georges Pompidou
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Paris、法国、75018
- Hôpital Bichat - Claude Bernard
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Pessac、法国、33604
- Hopital Haut Leveque
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Pontoise、法国、95301
- Clinique Ste - Marie
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Reims、法国、51092
- CHU - Robert Debre
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Rennes、法国、35064
- Centre Eugene Marquis
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Rouen、法国、76031
- Hopital Charles Nicolle
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Saint Brieuc、法国、F-22015
- Clinique Armoricaine de Radiologie
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Saint Martin Boulogne、法国、62280
- Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault
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Saint-Quentin、法国、02321
- Centre Hospitalier de Saint-Quentin
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Semur en Auxois、法国、21140
- Centre Hospitalier de Semur en Auxois
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Soissons cedex、法国、02209
- Centre Hospitalier de Soissons
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Strasbourg、法国、67098
- Hopital Universitaire Hautepierre
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Tarbes、法国、65013
- Centre hospitalier de Tarbes
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Valence、法国、26000
- Nouvelle Clinique Generale
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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 or cytologically confirmed adenocarcinoma of the pancreas or ampulla
- Metastatic disease
- Unresectable disease
Measurable disease, meeting the following criteria:
- No prior radiotherapy to the only site of measurable disease
- Diameter > 10 mm by spiral CT scan or MRI OR > 20 mm by conventional methods
- No brain metastases
PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Life expectancy > 2 months
- No contraindication to chemotherapy
- Creatinine clearance > 60 mL/min
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Alkaline phosphatase < 5 times normal
- Bilirubin ≤ 3 mg/dL
- No coronary insufficiency
- No symptomatic cardiac disease
- Good hydration possible
- No Child-Pugh class B or C cirrhosis
- No other malignancy except for basal cell skin cancer or carcinoma in situ of the cervix
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior palliative or adjuvant chemotherapy
- At least 4 weeks since prior radiotherapy
- No radiotherapy during or for 4 weeks after study therapy
- No other concurrent anticancer therapy
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器:LV5FU2 simplifié + cisplatine puis gemcitabine si progression
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实验性的:gemcitabine puis LV5FU2 simplifié + cisplatine si progression
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
总生存期
大体时间:2012
|
2012
|
次要结果测量
结果测量 |
大体时间 |
---|---|
毒性
大体时间:2012
|
2012
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Progression-free survival
大体时间:2012
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2012
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Quality of life
大体时间:2012
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2012
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Percentage of patients needing second-line therapy
大体时间:2012
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2012
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Duration of hospitalization
大体时间:2012
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2012
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合作者和调查者
调查人员
- 学习椅:Jean-Francois Seitz, MD、CHU de la Timone
- 学习椅:Jean-Louis Legoux, MD、Hopital Haut Leveque
- 学习椅:Pascal Hammel, MD, PhD、Hôpital Beaujon
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
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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