Prostate Cancer Clinical Trial
Official title:
Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma
RATIONALE: Drugs used in chemotherapy, such as capecitabine 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 capecitabine together with
docetaxel works in treating patients with metastatic prostate cancer.
OBJECTIVES:
Primary
- Determine the response rate in patients with androgen-independent metastatic
adenocarcinoma of the prostate treated with capecitabine and docetaxel.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the progression-free survival, time to treatment failure, and overall
survival of patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and oral capecitabine
twice daily on days 5-18. Courses repeat every 28 days in the absence of disease progression
or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional
courses of therapy beyond CR
After completion of study treatment, patients are followed periodically for survival.
PROJECTED ACCRUAL: A total of 28 patients will be accrued for this study.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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