Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase II Trial of Capecitabine (Xeloda) and Weekly Docetaxel (Taxotere) in Metastatic Androgen Independent Prostate Carcinoma

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel & Capecitabine<br>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 | Drug: capecitabine<br>* 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<br>* Other names: Xeloda®;Drug: docetaxel<br>* 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<br>* Other names: Taxotere®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate by RECIST criteria after every 2 courses |  | at cycle 2 and every other cycle thereafter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity at 30 days after last treatment |  | Every week during treatment cycles | 
| Progression-free survival |  | 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. | Every 2 cycles | 
| Overall survival |  | Every 2 cycles | 
| Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase) |  | Every week during treatment cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate