Docetaxel in Treating Patients With Relapsed Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00482274|
Recruitment Status : Terminated (Drug supplier stopped funding due to loss of study drug (docetaxel) patent.)
First Posted : June 5, 2007
Results First Posted : August 24, 2010
Last Update Posted : April 28, 2017
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 or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: docetaxel||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (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.|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||July 2009|
- 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) ]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 ]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) ]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) ]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) ]Due to the limited enrollment, this analysis was not completed.
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): 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|