Epirubicin and Docetaxel in Treating Patients With Metastatic Prostate Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the prostate
• Meets 1 of the following criteria:
• Measurable disease with any prostate-specific antigen (PSA) value
• Unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
• Histologic confirmation required if measurable disease is confined to a solitary lesion
• Non-measurable disease with PSA ≥ 5 ng/mL*
• The following are considered non-measurable disease:
• Bone lesions
• Pleural or pericardial effusion
• Ascites
• CNS lesions
• Leptomeningeal disease
• Irradiated lesions unless disease progression was documented after prior radiotherapy NOTE: *Patients with PSA ≥ 5 ng/mL only are not eligible
• Progressive systemic disease despite ≥ 1 prior standard endocrine therapy with orchiectomy, luteinizing hormone-releasing hormone (LHRH) agonist, or diethylstilbestrol, as indicated by 1 of the following criteria:
• Objective evidence of increase > 20% in the sum of the longest diameters of target lesions from the time of maximal regression OR the appearance of 1 or more new lesions
• One or more new lesions on bone scan secondary to prostate cancer AND PSA ≥ 5 ng/mL
• Elevated PSA (≥ 5 ng/mL) with 2 consecutive increases from baseline (taken ≥ 1 week apart)
• Serum testosterone ≤ 50 ng/dL for patients without bilateral orchiectomy
• Patients who have not had a bilateral orchiectomy should continue therapy with primary testicular androgen suppression (e.g., LHRH analogues)

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-2

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3

Hepatic

• Meets 1 of the following criteria:
• AST or ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
• AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
• AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal
• Bilirubin normal

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No uncontrolled high blood pressure
• No unstable angina
• No symptomatic congestive heart failure
• No myocardial infarction within the past 6 months
• No serious uncontrolled cardiac arrhythmia
• No New York Heart Association class III or IV heart disease

Other

• Fertile patients must use effective contraception during and for at least 3 months after study participation
• No peripheral neuropathy ≥ grade 2
• No prior severe hypersensitivity reaction to docetaxel or other drug formulated with polysorbate 80

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

Chemotherapy

• No prior chemotherapy, including estramustine or suramin for prostate cancer
• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• At least 4 weeks since prior antiandrogen therapy
• No concurrent hormonal therapy except steroids for adrenal insufficiency, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

Radiotherapy

• See Disease Characteristics
• At least 4 weeks since prior radiotherapy
• At least 8 weeks since prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium
• No concurrent palliative radiotherapy

Surgery

• See Disease Characteristics
• At least 4 weeks since prior surgery and recovered