Docetaxel, Doxorubicin, and Prednisone in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy

OBJECTIVES:

Primary

• Assess prostate specific antigen response rate to docetaxel, doxorubicin hydrochloride, and prednisone in patients with hormone-refractory advanced prostate cancer.

Secondary

• Assess if treatment with docetaxel, doxorubicin hydrochloride, and prednisone will improve health-related quality of life of these patients.
• Assess the toxicity of docetaxel, doxorubicin hydrochloride, and prednisone.
• Assess response rate in measurable disease.

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.

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate with any of the following:

• Prostate-specific antigen ≥ 10 mg/dL
• Bone disease
• Bidimensional soft tissue disease
• Evaluable disease
• 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:

• Inactive nonmelanoma skin cancer
• Disease-free for five or more years
• Adequately treated stage I or II cancer from which patient is currently in complete remission
• 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:

• See Disease Characteristics
• No new hormonal treatment within the past 4 weeks
• No prior immunotherapy, chemotherapy, or bone-seeking radiopharmaceuticals (e.g., strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium)
• Prior bisphosphonates allowed
• At least 2 weeks since prior radiotherapy
• No other concurrent chemotherapy