Status:
COMPLETED
Capecitabine and Docetaxel in Treating Patients With Metastatic Prostate Cancer
Lead Sponsor:
Barbara Ann Karmanos Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
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. Givi...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2007
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00258284
Start Date
August 1 2003
End Date
November 1 2007
Last Update
March 6 2014
Active Locations (1)
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1
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States, 48201-1379