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
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Supportive Care
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
John A. Glaspy, MD, MPH
Jonsson Comprehensive Cancer Center
United States: Food and Drug Administration
|Jonsson Comprehensive Cancer Center, UCLA||Los Angeles, California 90095-1781|