Docetaxel in Treating Patients With Relapsed Prostate Cancer
This study is currently recruiting patients.
Verified by National Cancer Institute (NCI) May 2007
| Sponsors and Collaborators: |
Oregon Health and Science University
|
| Information provided by: |
National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: |
NCT00482274 |
|
Purpose
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
Procedure: chemotherapy
|
Phase II
|
MedlinePlus
related topics:
Prostate Cancer
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.
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
-
Complete response rate as measured by serum PSA
Secondary Outcome Measures:
-
Time to PSA recurrence as seen by 2 measurements performed a week apart
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Time to metastatic disease
-
Time to androgen independent state
-
Time to death from any cause
Total Enrollment: 36
Study start: May 2007
OBJECTIVES:
Primary
-
Determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel.
Secondary
-
Determine the time to PSA recurrence in patients receiving this treatment.
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Determine the time to metastatic disease in patients receiving this treatment.
-
Determine the time to androgen independent state in patients receiving this treatment.
-
Determine the time to death from any cause in patients receiving this treatment.
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.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Male
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
-
ECOG performance status 0-2
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Life expectancy ≥ 3 months
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Absolute granulocyte count ≥ 1,200/mm³
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Platelet count ≥ 100,000/mm³
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Bilirubin normal
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AST ≤ 1.5 times upper limit of normal (ULN) if alkaline phosphatase is not normal
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Alkaline phosphatase ≤ 5 times ULN if AST and ALT are not normal
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Creatinine ≤ 2 times ULN
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No other active malignancy within the past 5 years, except for adequately treated nonmelanoma skin cancer
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No peripheral neuropathy ≥ grade 2
PRIOR CONCURRENT THERAPY:
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00482274
United States, Oregon
Oregon Health & Science University Cancer Institute, Portland, Oregon, 97239-3098, United States; Recruiting
Tomasz M. Beer, MD 503-494-0365
United States, Washington
University Cancer Center at University of Washington Medical Center, Seattle, Washington, 98195-6043, United States; Recruiting
Clinical Trials Office - University of Washington Cancer Cente 206-616-8289
Study chairs or principal investigators
Tomasz M. Beer, MD, Principal Investigator, Oregon Health and Science University
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000546975; OHSU-2838; OHSU-SOL-06076-LM
Last Updated: June 6, 2007
Record first received: June 4, 2007
ClinicalTrials.gov Identifier:
NCT00482274
Health Authority: Unspecified
 
