Prostate Cancer Clinical Trial
Official title:
Phase II Trial of Gemcitabine And Docetaxel In Androgen-Independent Metastatic Prostate Cancer
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and docetaxel, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving gemcitabine together with docetaxel
works in treating patients with metastatic prostate cancer.
OBJECTIVES:
- Determine the objective response rate and toxicity in patients with
androgen-independent metastatic prostate cancer treated with gemcitabine hydrochloride
and docetaxel.
OUTLINE: This is an open-label study.
Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 followed by
docetaxel IV over 60 minutes on day 8. Treatment repeats every 3 weeks for up to 6 courses
in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for at least 5
years.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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