Docetaxel in Treating Patients With Relapsed Prostate Cancer
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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.|
- Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml [ Time Frame: While receiving study treatment (approximately 6 months) ] [ Designated as safety issue: No ]Complete response rate, as measured by PSA and defined as a PSA ≤0.2 ng/ml in PSA-relapsed, hormone-sensitive patients treated with docetaxel.
- Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml) [ Time Frame: Average days to develop recurrence from treatment start date amount applicable participants ] [ Designated as safety issue: No ]Average time for participants to develop PSA recurrence (PSA > 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.
- Time to Metastatic Disease [ Time Frame: Measured at Time of documented metastases (no historical estimate is available) ] [ Designated as safety issue: No ]Due to the limited enrollment, this analysis was not completed.
- Time to Androgen Independent State [ Time Frame: Measured at date of documented androgen independence (no estimate available) ] [ Designated as safety issue: No ]Due to the limited enrollment, this analysis was not completed.
- Time to Death From Any Cause [ Time Frame: measured at date of death (no estimate available) ] [ Designated as safety issue: No ]Due to the limited enrollment, this analysis was not completed.
|Study Start Date:||May 2007|
|Study Completion Date:||July 2009|
|Primary Completion Date:||July 2009 (Final data collection date for primary outcome measure)|
- Determine the complete response rate in patients with biochemically-relapsed, hormone-sensitive prostate cancer treated with docetaxel.
- Determine the time to PSA recurrence in patients receiving this treatment.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482274
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239-3098|
|United States, Washington|
|University Cancer Center at University of Washington Medical Center|
|Seattle, Washington, United States, 98195-6043|
|Principal Investigator:||Tomasz M. Beer, MD||OHSU Knight Cancer Institute|