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Sponsors and Collaborators: |
Oregon Health and Science University Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00482274 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Drug: docetaxel |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Study of the Early Use of Docetaxel in Patients With Biochemical Relapse After Primary Therapy for Prostate Cancer and an Incomplete Response to Androgen Deprivation Therapy. |
Estimated Enrollment: | 36 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is an open label study.
Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of unacceptable toxicity or disease progression.
After completion of study therapy, patients are followed periodically for up to 5 years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Nadir serum PSA > 0.2 ng/dL after the initiation of androgen deprivation therapy
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
More than 28 days since prior corticosteroids except for inhaled or topical steroids
United States, Oregon | |
Oregon Health and Science University Cancer Institute | Recruiting |
Portland, Oregon, United States, 97239-3098 | |
Contact: Tomasz M. Beer, MD 503-494-0365 | |
United States, Washington | |
University Cancer Center at University of Washington Medical Center | Recruiting |
Seattle, Washington, United States, 98195-6043 | |
Contact: Clinical Trials Office - University Cancer Center at Universit 206-616-8289 |
Principal Investigator: | Tomasz M. Beer, MD | Oregon Health and Science University Cancer Institute |
Responsible Party: | Oregon Health and Science University Cancer Institute ( Tomasz M. Beer ) |
Study ID Numbers: | CDR0000546975, OHSU-2838, OHSU-SOL-06076-LM |
Study First Received: | June 4, 2007 |
Last Updated: | December 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00482274 |
Health Authority: | Unspecified |
adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer |
stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
Docetaxel Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |