Study Objective: This protocol is designed to evaluate the effectiveness of using ethanol (dehydrated alcohol, USP) to restore patency in central venous access devices (CVADs) through which paclitaxel [(Taxol, Bristol- Myers Oncology Div., Princeton, New Jersey], has been administered. Paclitaxel is a cancer chemotherapy drug that in its clinical formulation is solubilized in a 50:50 mixture of Cremaphor EL and dehydrated alcohol, USP. Clinical experience and a literature review have demonstrated that CVADs frequently develop an accumulation of blood and drug residues, or sludge. The sludge, in turn, contributes to CVAD malfunction-the inability to aspirate blood from or instill fluid into the catheter. Methods: Because paclitaxel is more highly soluble in ethanol than in aqueous media, this study is evaluating whether CVAD occlusions associated with paclitaxel administration can be cleared by using urokinase followed by ethanol instillation. Summary of Findings: Five subjects who underwent a total of nine interventions have been enrolled and data analysis is in progress. Future enrollment has been terminated because this subject population is no longer being admitted to the Clinical Center.

Agency
National Institute of Health (NIH)
Institute
Clinical Center (CLC)
Type
Intramural Research (Z01)
Project #
1Z01CL001113-04
Application #
6161466
Study Section
Nursing Research Study Section (NURS)
Project Start
Project End
Budget Start
Budget End
Support Year
4
Fiscal Year
1997
Total Cost
Indirect Cost
Name
Clinical Center
Department
Type
DUNS #
City
State
Country
United States
Zip Code