Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 3
Healthy volunteers: no

Brief 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.

Arms:

Interventions: intervention 1: docetaxel
Intervention descriptions: intervention 1: Docetaxel 75 mg/m2 intravenously (IV) over 60 minutes will be given on day 1 of each 21 day cycle.

Protocol document: