Prostate Cancer
Conditions
Keywords
recurrent prostate cancer, stage IV prostate cancer, adenocarcinoma of the prostate
Brief summary
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
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.
Interventions
DRUGcapecitabine
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
DRUGdocetaxel
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
Sponsors
National Cancer Institute (NCI)
Barbara Ann Karmanos Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate by RECIST criteria after every 2 courses | at cycle 2 and every other cycle thereafter |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity at 30 days after last treatment | Every week during treatment cycles | — |
| Progression-free survival | Every 2 cycles | — |
| Time to treatment failure | Every 2 cycles | From date of registration to date of progressive disease, or date patient is taken off study for any other reason. |
| Overall survival | Every 2 cycles | — |
| Effect of treatment on biological correlates (thymidine phosphorylase, dihydropyrimidine dehydrogenase, thymidylate synthase) | Every week during treatment cycles | — |
Countries
United States
Outcome results
None listed