DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer
|ClinicalTrials.gov Identifier: NCT00024401|
Recruitment Status : Unknown
Verified June 2002 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 15, 2004
Last Update Posted : July 24, 2008
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.
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Drug: DHA-paclitaxel||Phase 2|
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.
|Study Type :||Interventional (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|
|Study Start Date :||May 2001|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00024401
|United States, Arizona|
|Arizona Oncology Associates|
|Tucson, Arizona, United States, 85712-2254|
|United States, District of Columbia|
|Veterans Affairs Medical Center - Washington, DC|
|Washington, District of Columbia, United States, 20422|
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center, Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|United States, Kentucky|
|Albert B. Chandler Medical Center, University of Kentucky|
|Lexington, Kentucky, United States, 40536-0084|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, New Jersey|
|Veterans Affairs Medical Center - East Orange|
|East Orange, New Jersey, United States, 07018-1095|
|Study Chair:||Ross C. Donehower, MD||Sidney Kimmel Comprehensive Cancer Center|