Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Prostate Cancer

About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring recurrent prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Metastatic disease Androgen-independent disease Progressive disease, as documented by ≥ 1 of the following criteria: Rising prostate-specific antigen (PSA) despite androgen deprivation therapy and anti-androgen withdrawal Demonstrates a rising PSA trend with 2 successive elevations ≥ 1 week apart Measurable disease progression Nonmeasurable disease progression, defined as the following: PSA ≥ 5 ng/mL New areas of bone metastases on bone scan Serum testosterone ≤ 0.5 ng/mL (castrate level) Concurrent luteinizing hormone-releasing hormone agonist therapy required for medically castrated patients PATIENT CHARACTERISTICS: Performance status Zubrod 0-2 Life expectancy At least 12 weeks Hematopoietic Absolute neutrophil count ≥ 1,500/ mm^3 Hemoglobin ≥ 8.0 g/dL Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin normal Transaminases meeting 1 of the following criteria: AST and/or ALT ≤ 2.5 times upper limit of normal (ULN) if alkaline phosphatase (AP) normal AP ≤ 4 times ULN if AST and/or ALT normal Renal Creatinine clearance ≥ 50 mL/min OR Creatinine ≤ 2 mg/dL Cardiovascular No congestive heart failure No second- or third-degree heart block No myocardial infarction within the past 3 months Other Fertile patients must use effective contraception during and for 6 months after completion of study treatment No other malignancy within the past 2 years except adequately treated skin cancer or other cancer in complete remission No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 No peripheral neuropathy ≥ grade 2 PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy for metastatic disease Endocrine therapy See Disease Characteristics More than 4 weeks since prior flutamide More than 6 weeks since prior bicalutamide or nilutamide Radiotherapy At least 4 weeks since prior radiotherapy Other At least 28 days since prior investigational drugs for prostate cancer No other concurrent anti-cancer therapy
Sites / Locations
- Barbara Ann Karmanos Cancer Institute
Arms of the Study
Arm 1
Experimental
Docetaxel & Capecitabine
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