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.
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. * 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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle.
OHSU Knight Cancer Institute
Portland, Oregon, United States
University Cancer Center at University of Washington Medical Center
Seattle, Washington, United States
Number of Participants With a Complete Response as Measured by Serum PSA Less Than 0.2 ng/ml
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.
Time frame: While receiving study treatment (approximately 6 months)
Average Time for Participants to Develop PSA Recurrence (PSA > 0.2ng/ml)
Average time for participants to develop PSA recurrence (PSA \> 0.2ng/ml). Due to the limited enrollment, this analysis was not completed.
Time frame: Average days to develop recurrence from treatment start date amount applicable participants
Time to Metastatic Disease
Due to the limited enrollment, this analysis was not completed.
Time frame: Measured at Time of documented metastases (no historical estimate is available)
Time to Androgen Independent State
Due to the limited enrollment, this analysis was not completed.
Time frame: Measured at date of documented androgen independence (no estimate available)
Time to Death From Any Cause
Due to the limited enrollment, this analysis was not completed.
Time frame: measured at date of death (no estimate available)
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