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