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