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About
RATIONALE: Drugs used in chemotherapy, such as docetaxel, doxorubicin, and prednisone, 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 docetaxel, doxorubicin, and prednisone together works in treating patients with advanced prostate cancer that has not responded to hormone therapy.
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1, doxorubicin hydrochloride IV over 15 minutes on days 1 and 8, and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for at least 3 courses in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed at baseline, on day 1 of each course, after completion of 3 courses, and at disease progression.
After completing study treatment, patients are followed every 6 months for 1 year.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate with any of the following:
Advanced disease AND failed prior primary androgen ablation therapy, including anti-androgen withdrawal
Disease not amenable to local curative treatment
No known brain metastases
PATIENT CHARACTERISTICS:
ECOG performance status 0-1
Absolute neutrophil count ≥ 1,500/mm^3
Platelet count ≥ 100,000/mm^3
Creatinine < 2.0 mg/dL
SGPT and SGOT < 1.5 times upper limit of normal (ULN)
Bilirubin ≤ ULN
Hemoglobin ≥ 10 g/dL
Ejection fraction ≥ 50%
Peripheral neuropathy ≤ grade 1
Fertile patients must use effective contraception during and for 3 months after completion of study treatment
No previous history of or concurrent malignancy, except for any of the following:
No other serious medical illness that would limit survival to less than 3 months
No psychiatric condition that would prevent informed consent
No active, uncontrolled bacterial, viral, or fungal infection
No hemorrhagic disorder
No history of severe hypersensitivity reaction to other drugs formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
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Data sourced from clinicaltrials.gov
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