Gemcitabine With or Without Dalteparin in Treating Patients With Unresectable or Metastatic Pancreatic Cancer
A Prospective Randomized Controlled Multicenter Study of the Effect of Dalteparin on Quality of Life in Unresectable Pancreatic Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Anticoagulants such as dalteparin may help prevent blood clots in patients being treated with gemcitabine for unresectable or metastatic pancreatic cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of gemcitabine with or without dalteparin in treating patients who have unresectable or metastatic pancreatic cancer.
研究概览
详细说明
OBJECTIVES:
- Compare the quality of life of patients with unresectable or metastatic pancreatic cancer treated with gemcitabine with or without dalteparin.
- Compare the survival of patients treated with these regimens.
- Compare the incidence of venous thromboembolic complications in patients treated with these regimens.
- Determine the safety of dalteparin, in terms of bleeding complications, in these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (unresectable nonmetastatic vs metastatic). Patients are randomized to one of two treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 for the first course only. Beginning on week 9, patients receive gemcitabine IV over 30 minutes once weekly for 3 weeks. Treatment then repeats every 4 weeks for up to 6 months in the absence of unacceptable toxicity or disease progression.
- Arm II: Patients receive gemcitabine as in arm I and dalteparin subcutaneously once daily for 6 months in the absence of unacceptable toxicity.
Quality of life is assessed at baseline and every 4 weeks during study therapy.
Patients are followed every 4 weeks.
PROJECTED ACCRUAL: A total of 400 patients (200 per treatment arm) will be accrued for this study within 40 months.
研究类型
注册 (预期的)
阶段
- 第三阶段
联系人和位置
学习地点
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Alabama
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Mobile、Alabama、美国、36607
- MBCCOP - Gulf Coast
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Colorado
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Denver、Colorado、美国、80224
- CCOP - Colorado Cancer Research Program, Incorporated
-
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Illinois
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Chicago、Illinois、美国、60612-7323
- MBCCOP - University of Illinois at Chicago
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Decatur、Illinois、美国、62526
- CCOP - Central Illinois
-
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Michigan
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Kalamazoo、Michigan、美国、49007-3731
- CCOP - Kalamazoo
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Missouri
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Kansas City、Missouri、美国、64131
- CCOP - Kansas City
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New York
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East Syracuse、New York、美国、13057
- CCOP - Hematology-Oncology Associates of Central New York
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Rochester、New York、美国、14642
- University of Rochester Cancer Center CCOP Research Base
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North Carolina
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Goldsboro、North Carolina、美国、27534-9479
- CCOP - Southeast Cancer Control Consortium
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Ohio
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Columbus、Ohio、美国、43215
- CCOP - Columbus
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Dayton、Ohio、美国、45429
- CCOP - Dayton
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South Carolina
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Greenville、South Carolina、美国、29615
- CCOP - Greenville
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Washington
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Tacoma、Washington、美国、98405-0986
- CCOP - Northwest
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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 pancreatic adenocarcinoma or poorly differentiated carcinoma of the pancreas that is considered ineligible for curative resection
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- Eastern Cooperative Oncology Group 0-2
Life expectancy:
- Not specified
Hematopoietic:
- White Blood Cell count greater than 3,500/mm^3
- Platelet count greater than 100,000/mm^3
- No clinically significant bleeding disorder
- No prior heparin-induced thrombocytopenia
Hepatic:
- Bilirubin less than 2.0 mg/dL
- aspartate aminotransferase less than 3 times normal
Renal:
- Creatinine less than 2.0 mg/dL
Cardiovascular:
- No prior hemorrhagic stroke
- No uncontrolled hypertension (sustained blood pressure greater than 200 mm Hg systolic or 110 mm Hg diastolic)
Other:
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No other active malignancy
- No gastrointestinal bleeding within the past 30 days
- No contraindications to anticoagulation
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- Not specified
Chemotherapy:
- No prior chemotherapy for metastatic disease
- Prior adjuvant chemotherapy allowed
Endocrine therapy:
- Not specified
Radiotherapy:
- At least 4 weeks since prior radiotherapy and recovered
Surgery:
- Prior surgical resection allowed
- At least 4 weeks since prior surgery with non-curative intent and recovered
- More than 30 days since prior neurologic or ophthalmologic surgery
Other:
- At least 2 weeks since prior low-molecular-weight heparin
- More than 30 days since prior experimental therapeutic agent
- No concurrent heparin or warfarin for pre-existing condition
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 |
---|---|
实验性的:Dalteparin
5,000 anti-Xa units of dalteparin subcutaneously once daily for six months in addition to gemcitabine at 1,000 mg/m2 as a 30-minute infusion weekly for 7 weeks followed by a week of rest for the first cycle and weekly for three weeks followed by a week of rest for each subsequent cycle.
|
研究衡量的是什么?
主要结果指标
结果测量 |
---|
Quality of life as measured by FACT-Hep version 4 every 4 weeks
|
次要结果测量
结果测量 |
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生存
|
Frequency of symptomatic venous thromboembolic complications
|
Safety as measured by the occurrence of bleeding complications
|
合作者和调查者
赞助
调查人员
- 学习椅:Kishan J. Pandya, MD、University of Rochester
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
与本研究相关的术语
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