Phase II Open-Label Study of Taxoperxin (DHA-Paclitacel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Cancer of the Colon/Rectum
OBJECTIVES: I. Determine the objective tumor response rate, duration of response, and time
to disease progression in patients with metastatic colorectal cancer treated with
DHA-paclitaxel. II. Determine the overall survival of patients treated with this drug. III.
Determine the toxicity profile of this drug in these patients. IV. Assess the quality of
life of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day
1. Treatment repeats every 21 days in the absence of disease progression or unacceptable
toxicity. Quality of life is assessed at baseline, every 2 courses, and at end of study
treatment. Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 18-50 patients will be accrued for this study.
Primary Purpose: Treatment
Ross C. Donehower, MD
Sidney Kimmel Comprehensive Cancer Center
United States: Federal Government
|Albert B. Chandler Medical Center, University of Kentucky||Lexington, Kentucky 40536-0084|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University||Chicago, Illinois 60611|
|Veterans Affairs Medical Center - East Orange||East Orange, New Jersey 07018-1095|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins||Baltimore, Maryland 21231-2410|
|Veterans Affairs Medical Center - Washington, DC||Washington, District of Columbia 20422|
|Arizona Oncology Associates||Tucson, Arizona 85712-2254|