DHA-Paclitaxel in Treating Patients With Metastatic Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00024414|
Recruitment Status : Unknown
Verified March 2003 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : January 27, 2003
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 prostate cancer that has not responded to hormone therapy.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: DHA-paclitaxel||Phase 2|
- Determine the objective tumor response rate or prostate-specific antigen response, duration of response, and time to disease progression in patients with metastatic hormone-refractory prostate cancer treated with DHA-paclitaxel.
- Determine the overall survival of patients treated with this drug.
- Determine the toxicity profile of this drug in these patients.
- 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 off study.
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 Taxoprexin (DHA-Paclitaxel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Hormone-Refractory Prostate Cancer|
|Study Start Date :||April 2001|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00024414
|United States, Arizona|
|Arizona Oncology Associates|
|Tucson, Arizona, United States, 85712-2254|
|United States, California|
|Alta Bates Comprehensive Cancer Center|
|Berkeley, California, United States, 94704|
|United States, Kentucky|
|Lucille Parker Markey Cancer Center, University of Kentucky|
|Lexington, Kentucky, United States, 40536-0098|
|United States, Louisiana|
|Louisiana State University Health Sciences Center - Shreveport|
|Shreveport, Louisiana, United States, 71130-3932|
|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, 07019|
|United States, New York|
|Herbert Irving Comprehensive Cancer Center|
|New York, New York, United States, 10032|
|United States, Pennsylvania|
|Kimmel Cancer Center of Thomas Jefferson University - Philadelphia|
|Philadelphia, Pennsylvania, United States, 19107-5541|
|Study Chair:||Michael A. Carducci, MD||Sidney Kimmel Comprehensive Cancer Center|