NCT00462852已完成2 期
A Phase II Randomized Study of Chemo-Anticoagulation (Gemcitabine-Dalteparin) Versus Chemotherapy Alone (Gemcitabine) for Locally Advanced and Metastatic Pancreatic Adenocarcinoma [FRAGEM]
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 16
- 主要终点
- Incidence of venous thromboembolism reduction
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients being treated with gemcitabine for pancreatic cancer.
PURPOSE: This randomized phase II trial is studying how well gemcitabine works with or without dalteparin in treating patients with locally advanced or metastatic pancreatic cancer.
详细描述
OBJECTIVES:
Primary
- Compare the incidence of venous thromboembolism in patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine hydrochloride and dalteparin versus gemcitabine hydrochloride alone.
Secondary
- Compare the survival benefit, in terms of increased (from 70% to 85%) survival at 12 weeks, of patients treated with these regimens.
- Compare the toxicity of these regimens.
- Compare the overall survival of patients treated with these regimens.
- Compare the time to disease progression in patients treated with these regimens.
- Determine the effect of gemcitabine hydrochloride and dalteparin on serological markers of thromboangiogenesis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically or cytologically confirmed metastatic or locally advanced adenocarcinoma of the pancreas
- •Patients with clinical 'high probability' of pancreatic cancer and biopsy suggestive but not diagnostic of pancreatic cancer may be eligible based on review by the principal investigator
- •Measurable or evaluable disease
- •No clinical evidence of active venous thromboembolism
- •PATIENT CHARACTERISTICS:
- •Karnofsky performance status (PS) 60-100% OR WHO PS 0-2
- •Life expectancy > 12 weeks
- •Absolute neutrophil count > 2,000/mm³
- •WBC > 3,000/mm³
- •Platelet count > 100,000/mm³
- •Creatinine clearance > 50 mL/min
- •INR ≤ 1.5 times upper limit of normal (ULN)
- •Bilirubin < 1.5 times ULN (stent allowed)
- •Not pregnant or nursing
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •No cerebrovascular accident within the past 6 months
- •No obvious contraindication to anticoagulation, including the following:
- •Bleeding diathesis
- •Active peptic ulcer
- •Ulcerating cancer into duodenum
- •No history of other advanced malignancy
- •No gross hematuria
- •No melaena or gross evidence of gastrointestinal bleeding (other than piles)
- •No requirement for a central line
- •No other significant medial or psychiatric illness that, in the opinion of the investigator, would preclude study participation
- •PRIOR CONCURRENT THERAPY:
- •No prior gemcitabine hydrochloride-containing treatment
- •No other concurrent cytotoxic chemotherapy, immunotherapy, hormonal therapy (excluding contraceptives and replacement steroids), or experimental medications
- •No other concurrent specific anticancer therapy as a result of disease progression
- •No concurrent caval filter device
- •No other concurrent anticoagulants for venous thromboembolism or other reasons (e.g., atrial fibrillation)
- •No concurrent acetylsalicylic acid (> 75 mg) as an antiplatelet drug for a preexisting cardiovascular condition
- •No concurrent clopidogrel bisulfate
排除标准
- 未提供
结局指标
主要结局
Incidence of venous thromboembolism reduction
次要结局
- Early survival benefit
- Toxicity
- Overall survival
- Time to disease progression
- Effect of drug combination on serological markers of thromboangiogenesis
研究者
研究点 (16)
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