Docetaxel and Gemcitabine Compared With Docetaxel and Cisplatin in Treating Patients With Metastatic or Locally Advanced Pancreatic Cancer
Randomized Phase II Study of Docetaxel/Gemcitabine vs. Docetaxel/Cisplatin in Metastatic or Locoregionally Advanced Pancreatic Carcinoma
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether docetaxel plus gemcitabine is more effective than docetaxel plus cisplatin in treating advanced pancreatic cancer.
PURPOSE: Randomized phase II trial to compare the effectiveness of docetaxel and gemcitabine with that of docetaxel and cisplatin in treating patients who have metastatic or locally advanced pancreatic cancer.
研究概览
详细说明
OBJECTIVES: I. Assess the efficacy of docetaxel and gemcitabine vs docetaxel and cisplatin in patients with metastatic or locoregionally advanced pancreatic cancer. II. Assess the toxicity, response rate, duration of response, time to progression, survival, performance status, and weight associated with these treatment regimens in these patients.
OUTLINE: This is a randomized, open label, multicenter study. Patents are randomized to one of two treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Arm II: Patients receive docetaxel IV over 1 hour followed by cisplatin IV over 1 hour on day 1. Treatment is repeated every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 6 weeks until disease progression, and then every 8 weeks until death.
PROJECTED ACCRUAL: Up to 82 patients (41 per arm) will be accrued for this study.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
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Cairo、埃及
- National Cancer Institute of Egypt
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Amberg、德国、D-92224
- Klinikum St. Marien
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Essen、德国、D-45122
- Universitaetsklinik und Strahlenklinik - Essen
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Frankfurt、德国、D-60590
- Klinikum der J.W. Goethe Universitaet
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Hagen、德国、58095
- Marien Hospital
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Hamburg、德国、D-20099
- Hermann-Holthusen Institute for Radiotherapy
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Hannover、德国、D-30625
- Medizinische Hochschule Hannover
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Neustadt、德国、D-01844
- Praxis Innere Medizin
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Ulm、德国、D-89081
- Klinikum der Universitaet Ulm
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Brussels、比利时、1000
- Institut Jules Bordet
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Brussels、比利时、1070
- Hopital Universitaire Erasme
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Leuven、比利时、B-3000
- U.Z. Gasthuisberg
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Boulogne Billancourt、法国、F-92104
- CHU Ambroise Paré
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Vandoeuvre-les-Nancy、法国、54511
- Centre Alexis Vautrin
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Villejuif、法国、F-94805
- Institut Gustave Roussy
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Warsaw、波兰、02-781
- Maria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology
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Izmir、火鸡、35340
- Dokuz Eylul University School of Medicine
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Scotland
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Glasgow、Scotland、英国、G11 6NT
- Beatson Oncology Centre
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Roermond、荷兰、6043 CV
- Saint Laurentius Ziekenhuis
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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 metastatic or locoregionally advanced (with metastatic lymph nodes) unresectable adenocarcinoma of the exocrine pancreas Bidimensionally measurable disease outside previously irradiated fields No CNS involvement or leptomeningeal disease
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: WHO 0-1 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin less than 1.5 times the upper limit of normal (ULN) Renal: Creatinine no greater than ULN Other: No prior second malignancy in the past 10 years except carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin No psychological, familial, sociological, or geographical condition that precludes study compliance Not pregnant or nursing Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: Concurrent radiotherapy allowed if indicator lesions not included in irradiated field See Disease Characteristics Surgery: Not specified Other: No concurrent investigational drugs
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
合作者和调查者
调查人员
- 学习椅：Manfred Lutz, MD、Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
出版物和有用的链接
一般刊物
- Lutz MP, Van Cutsem E, Wagener T, Van Laethem JL, Vanhoefer U, Wils JA, Gamelin E, Koehne CH, Arnaud JP, Mitry E, Husseini F, Reichardt P, El-Serafi M, Etienne PL, Lingenfelser T, Praet M, Genicot B, Debois M, Nordlinger B, Ducreux MP; European Organisation for Research and Treatment of Cancer Gastrointestinal Group. Docetaxel plus gemcitabine or docetaxel plus cisplatin in advanced pancreatic carcinoma: randomized phase II study 40984 of the European Organisation for Research and Treatment of Cancer Gastrointestinal Group. J Clin Oncol. 2005 Dec 20;23(36):9250-6. doi: 10.1200/JCO.2005.02.1980.
- Lutz MP, Ducreux M, Wagener T, et al.: Docetaxel/gemcitabine or docetaxel/cisplatin in advanced pancreatic carcinoma: a randomized phase II study of the EORTC-GI group. [Abstract] Proceedings of the American Society of Clinical Oncology 21: A-498, 2002.
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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