Spots Global Cancer Trial Database for Docetaxel in Treating Patients With Relapsed Prostate Cancer

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Trial Identification

Brief Title: Docetaxel in Treating Patients With Relapsed Prostate Cancer

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 ID: NCT00482274

Conditions

Prostate Cancer

Interventions

docetaxel

Study Description

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.