Colorectal Cancer Clinical Trial
Official title:
Phase II Open-Label Study of Taxoperxin (DHA-Paclitacel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Cancer of the Colon/Rectum
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients
who have metastatic colorectal cancer.
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
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