Trials / Terminated
TerminatedNCT00482274
Docetaxel in Treating Patients With Relapsed Prostate Cancer
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.
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- OHSU Knight Cancer Institute · Academic / Other
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | docetaxel | Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle. |
Timeline
- Start date
- 2007-05-01
- Primary completion
- 2009-07-01
- Completion
- 2009-07-01
- First posted
- 2007-06-05
- Last updated
- 2017-04-28
- Results posted
- 2010-08-24
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00482274. Inclusion in this directory is not an endorsement.