Lymphoma Clinical Trial
Official title:
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
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.
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.
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