A Phase III Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effects of Fragmin (5,000 IU Subcutaneously) in Preventing Catheter-Related Complications When Given Daily to Cancer Patients With Central Venous Catheters
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 1
- 主要终点
- To determine if 5000 IU of Fragmin administered daily when compared to placebo will reduce the incidence of clinically relevant CRCs in cancer patients receiving chemotherapy by CVC
研究概览
简要总结
RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is effective in reducing these complications.
PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in preventing catheter-related complications in cancer patients who are receiving chemotherapy through a catheter.
详细描述
OBJECTIVES: I. Determine if dalteparin will reduce the incidence of clinically significant catheter related complications (i.e., asymptomatic catheter related thrombosis) in cancer patients receiving chemotherapy through a central venous catheter.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to treatment center and catheter placement (proximal to axilla vs distal to axilla). Patients are randomized to one of two treatment arms. Arm I: Patients receive dalteparin subcutaneously (SC) daily. Arm II: Patients receive placebo SC daily. Treatment continues for 16 weeks or until catheter removal in the absence of unacceptable toxicity. Patients are followed for 30 days.
PROJECTED ACCRUAL: A total of 345 patients (230 in arm I and 115 in arm II) will be accrued for this study over 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double
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
- •Histologically confirmed malignancy
- •No more than 5 days since placement of central venous catheter for administration of chemotherapy
- •Expected length of catheter use at least 16 weeks
- •18 and over
- •Performance status: ECOG 0-2
- •Life expectancy: At least 16 weeks
- •Hematopoietic:
- •Platelet count at least 100,000/mm3
- •Absolute neutrophil count at least 1,500/mm3
- •No known coagulopathy
- •Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) except in case of Gilbert's syndrome
- •AST no greater than 3 times ULN (no greater than 5 times ULN in case of liver metastases)
- •PT/PTT no greater than 1.5 times ULN Renal:
- •Creatinine no greater than 2 times ULN Cardiovascular:
- •HIV negative
- •Must weigh at least 90 pounds
- •At least 3 months since prior eye, ear, or CNS surgery Other:
- •At least 30 days since prior aspirin, dipyridamole, unfractionated heparin, other low molecular weight heparins, or other anticoagulation therapy (except heparin flushing)
排除标准
- •uncontrolled hypertension, unstable angina, or symptomatic congestive heart failure
- •myocardial infarction in past 6 months
- •uncontrolled cardiac arrhythmia Other:
- •known hypersensitivity (including heparin induced thrombocytopenia) to dalteparin, heparin, or other low molecular weight heparins
- •active uncontrolled infection, including existing catheter related infection
- •CNS trauma in past 3 months
- •retinal detachment in past 6 months
- •mental incapacitation or psychiatric illness that would preclude study compliance
- •other serious concurrent disease that would preclude study participation
- •active gastrointestinal or genitourinary tract bleeding
- •intracranial or intraocular hemorrhage in past year
- •concurrent high dose chemotherapy with stem cell transplantation
- •concurrent induction/consolidation chemotherapy for leukemia
- •concurrent high dose chemotherapy with stem cell transplantation
研究组 & 干预措施
Fragmin
Fragmin at 5000 IU injected subcutaneously daily
干预措施: Fragmin (Drug)
placebo
placebo injected subcutaneously daily
干预措施: placebo (Other)
结局指标
主要结局
To determine if 5000 IU of Fragmin administered daily when compared to placebo will reduce the incidence of clinically relevant CRCs in cancer patients receiving chemotherapy by CVC
时间窗: 16 weeks
次要结局
未报告次要终点