A Phase II Study of Estramustine, Docetaxel, and Carboplatin With G-CSF Support in Men With Hormone Refractory Prostate Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed stage IV adenocarcinoma of the prostate
Failure on standard hormone therapy Measurable disease with any PSA Accurately measured in
at least 1 dimension as at least 20 mm by physical exam for clinically palpable lymph
nodes and superficial skin lesions or chest x-ray for clearly defined lung lesions
surrounded by aerated lung OR those lesions measured as at least 10 mm by spiral CT scan
OR Nonmeasurable disease with PSA at least 5 ng/mL Nontarget lesions including small
lesions with longest diameter less than 20 mm by conventional techniques or less than 10
mm by spiral CT scan and truly nonmeasurable lesions including: Bone lesions Pleural or
pericardial effusions Ascites CNS lesions Leptomeningeal disease Irradiated lesions unless
progression documented after radiotherapy Documented progressive systemic disease despite
at least 1 endocrine manipulation with either orchiectomy or LHRH agonist (which must be
continued), or diethylstilbestrol For measurable disease: Objective evidence of increase
of greater than 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 For nonmeasurable disease:
If bone only disease, appearance of 1 new lesion on bone scan attributable to prostate
cancer along with a PSA of at least 5 ng/mL OR An elevated PSA (at least 5 ng/mL) that has
risen serially from baseline on 2 occasions each at least 1 week apart Testosterone no
greater than 50 ng/mL if no prior bilateral orchiectomy

PATIENT CHARACTERISTICS: Age: 18 to 99 Performance status: ECOG 0-2 Life expectancy: Not
specified Hematopoietic: WBC at least 3,000/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin no greater than 1.0 times upper limit of normal (ULN) AST no greater
than 1.5 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No
myocardial infarction or significant change in anginal pattern within past 1 year No
congestive heart failure No New York Heart Association class II-IV heart disease No deep
venous thrombosis or pulmonary embolus within past 1 year Other: Fertile patients must use
effective contraception No clinically significant peripheral neuropathy No known
hypersensitivity to E. coli derived products

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent sargramostim (GM-CSF)
Chemotherapy: No prior chemotherapy No prior estramustine or suramin No other concurrent
chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior
antiandrogens Primary testicular androgen suppression (e.g., with an LHRH analogue) should
not be discontinued Concurrent LHRH analogue allowed if no prior bilateral orchiectomy
Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiation and
recovered 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 major surgery and recovered