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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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
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
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Response rate by RECIST criteria after every 2 courses
Time frame: at cycle 2 and every other cycle thereafter
Toxicity at 30 days after last treatment
Time frame: Every week during treatment cycles
Progression-free survival
Time frame: Every 2 cycles
Time to treatment failure
From date of registration to date of progressive disease, or date patient is taken off study for any other reason.
Time frame: Every 2 cycles
Overall survival
Time frame: Every 2 cycles
Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase)
Time frame: Every week during treatment cycles
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