Phase I Trial of Epirubicin and Taxotere in Patients With Metastatic Androgen Independent Prostate Cancer

Inclusion Criteria

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