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