Capecitabine and Docetaxel 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