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| Sponsored by: |
Theradex |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00024414 |
Purpose
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 | Intervention | Phase |
|
Prostate Cancer |
Drug: DHA-paclitaxel |
Phase II |
| MedlinePlus related topics: | Cancer Prostate Cancer |
| Drug Information available for: | Paclitaxel DHA-paclitaxel |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 |
OBJECTIVES:
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the prostate
Progressive disease is defined by all of the following:
Serum testosterone level less than 50 ng/mL
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Neurologic:
Other:
No other prior or concurrent malignancy except:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| 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 | |||||
| Theradex |
| Study Chair: | Michael A. Carducci, MD | Sidney Kimmel Comprehensive Cancer Center |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068930, THERADEX-P01-00-04, JHOC-01011003, PROTARGA-P01-00-04 |
| First Received: | September 13, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00024414 |
| Health Authority: | United States: Federal Government |
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